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Released: November 30, 2011

Federal Communications Commission

FCC 11-176

Before the

Federal Communications Commission

Washington, D.C. 20554

In the Matter of
)
)

Amendment of Parts 2 and 95 of the
)
ET Docket No. 09-36
Commission’s Rules to Provide Additional
)
Spectrum for the Medical Device
)
RM-11404
Radiocommunication Service
)
in the 413-457 MHz band
)
)

REPORT AND ORDER

Adopted: November 30, 2011

Released: November 30, 2011

By the Commission: Chairman Genachowski and Commissioners Copps, McDowell, and Clyburn issuing
separate statements.

TABLE OF CONTENTS

Heading
Paragraph #
I.
INTRODUCTION .................................................................................................................................. 1
II. BACKGROUND .................................................................................................................................... 4
III. DISCUSSION....................................................................................................................................... 10
A. Medical Micro-Power Networks (MMNs)..................................................................................... 12
B. Frequency Bands............................................................................................................................ 23
C. Service and Technical Rules .......................................................................................................... 54
IV. PROCEDURAL MATTERS................................................................................................................ 95
V. ORDERING CLAUSES....................................................................................................................... 98
APPENDIX A - Final Rules
APPENDIX B - Final Regulatory Flexibility Analysis

I.

INTRODUCTION

1. By this Report and Order, we expand the Medical Device Radiocommunication (MedRadio)
Service under Part 95 of the Commission’s rules to permit the use of new wideband medical implant
devices that employ neuromuscular microstimulation techniques to restore sensation, mobility, and other
functions to paralyzed limbs and organs.1 These medical devices hold enormous promise to advance the
state of medical care, lower health costs, and improve the quality of life for countless Americans. The
rules we adopt will allow these new types of MedRadio devices to access 24 megahertz of spectrum in the
413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands on a secondary basis.
2. Each year, millions of Americans, including injured U.S. soldiers, suffer from spinal cord


1 Part 95 governs the Personal Radio Services, including General Mobile Radio Service, Radio Control Service and
Citizens Band (CB) Radio Service. The CB Radio Service, in turn, covers a number of specialized services such as
Family Radio Service, Low Power Radio Service, Medical Device Radiocommunication Service, Wireless Medical
Telemetry Service, Multi-Use Radio Service, and Dedicated Short-Range Communications Service.

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injuries, traumatic brain injuries, strokes, and various neuromusculoskeletal disorders. The devices that
we anticipate will operate under our new rules are designed to provide artificial nervous system functions
for these patients.
3. Our action is part of a larger effort to recognize and facilitate the significant advances in
wireless medical technologies that are revolutionizing treatment for a wide variety of medical conditions
and creating new health care models to benefit all Americans. Such advances have the potential to
significantly improve the quality of life and sophistication of therapy for countless Americans living with
a variety of medical conditions and, in turn, could result in lower medical costs and extend the time
between hospital visits and surgical procedures.2 The devices that we expect to be deployed under the
rules we adopt herein hold the promise of safer, less invasive, and more effective treatment options than
those available under current medical practice.

II.

BACKGROUND

4. The Commission has long recognized the importance of providing access to spectrum for
wireless medical communications technologies. Vital medical devices such as telemetry equipment that
transmit a patient’s pulse and respiration rates, implant devices that regulate heart rates, administer
medication, and treat neurological tremors; and sensor network systems that monitor physiological
parameters from multiple patients would not work without access to the electromagnetic spectrum. Our
support of the evolving needs of the medical radiocommunications community is equally longstanding.
Nearly forty years ago, the Commission authorized the use of the 460-470 MHz band for low-power
biomedical telemetry operations in medical facilities and convalescent centers. The Commission later
designated spectrum in the 608-614 MHz, 1395-1400 MHz, and 1429-1432 MHz bands for the Wireless
Medical Telemetry Service (WMTS) under Part 95 of its Rules in response to increased use of medical
telemetry and expanding spectrum challenges.3
5. The continued development of new medical radio devices, including increasing numbers of
implanted devices, also led the Commission to establish the Medical Implant Communication Service
(MICS) in 1999.4 For the MICS, the Commission set aside three megahertz of spectrum at 402-405 MHz
on a license-by-rule basis under Part 95 expressly for short-range wireless links between ultra-low power
medical implant transmitters and associated programmer/control equipment.5 These rules supported the
development of implant devices such as cardiac pacemakers and defibrillators that also monitor and report
cardiac condition. Most recently, the Commission created the MedRadio Service in the 401-406 MHz


2 Americans spent approximately $73.7 billion in 2010 for stroke-related medical costs and disability; a
comprehensive study of the economic burden of injury estimated that, for traumatic brain injuries incurred in the
U.S. over a one year period, the lifetime direct and indirect costs of those injuries totaled approximately $60 billion;
and the estimated average lifetime costs for a person with cerebral palsy are approximately $921,000. See Alfred
Mann Foundation ex parte, ET Docket No. 09-36, filed November 15, 2011 at 1-2 (citing American Stroke
Association and Centers for Disease Control and Prevention).
3
Amendment of Parts 2 and 95 of the Commission's Rules to Create a Wireless Medical Telemetry Service,
ET Docket No. 99-255, PR Docket No. 92-235, Report and Order, 15 FCC Rcd 11206 (2000). 47 C.F.R. §
95.401(e). “Wireless medical telemetry” is defined in the rules governing WMTS as “the measurement and
recording of physiological parameters and other patient-related information via radiated bi-or unidirectional
electromagnetic signals.” See 47 C.F.R. § 95.1103 (c). Voice and video communications are expressly prohibited in
the WMTS bands. However, the Commission decided that, for the purposes of its service definition, waveforms
such as electrocardiograms (ECGs) would not be considered video communications. 47 C.F.R. § 95.1117(a).
4 Amendment of Parts 2 and 95 of the Commission’s Rules to Establish a Medical Implant Communications Service
in the 402-405 MHz Band, WT Docket No. 99-66, Report and Order, 14 FCC Rcd 21040 (1999) (MICS R&O);
47 C.F.R. Part 95, Subpart E (Technical Regulations) and Subpart I (Medical Implant Communications).
5 See MICS R&O at 21043-46 paras. 8, 10, 15.
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band.6 MedRadio, which includes legacy MICS operations, represents an umbrella framework to regulate
the operation of both implanted and body-worn wireless medical devices used for diagnostic and
therapeutic purposes in humans.
6. The WMTS and MedRadio services, together with unlicensed medical applications developed
and operated under our general Part 15 rules, have supported countless vital therapeutic and diagnostic
medical applications. We recognize, however, that the dynamic nature of medical technology means that
our existing rules may need to evolve to keep pace with the newest cutting edge therapies. Thus, the
Commission included in the MedRadio Proceeding a notice of inquiry seeking information in a broader
context relating to future spectrum needs for wireless medical technologies.7 On September 5, 2007, the
Alfred Mann Foundation for Scientific Research (AMF or Alfred Mann) filed a petition for rulemaking
that serves as the basis of this proceeding.8
7. In its petition, Alfred Mann asked the Commission to designate up to 24 megahertz of
spectrum in the 413-457 MHz range to support new medical micro-power networks (MMNs) consisting
of implantable neuromuscular microstimulation devices and associated external control units. Alfred
Mann’s petition was based on its research dating to 1989 on implantable medical devices to treat
neurological injuries and disorders.9 Since 2005, AMF has conducted extensive work under the authority
of an experimental license from the Commission to operate its devices in the 400-470 MHz band.10
Alfred Mann’s wideband MMN equipment is designed to replace damaged nerve connections by
performing functional electric stimulation (FES) to activate and monitor nerves and muscles in order to
restore sensation, mobility, and other functions to nonfunctioning limbs and organs.11
8. The Commission released a Notice of Proposed Rulemaking (NPRM) on March 20, 2009, that
proposed to allocate 24 megahertz of spectrum in four segments of the 413-457 MHz band for MMN
devices.12 In the NPRM, we sought comment on providing access to spectrum in the 413-419 MHz, 426-
432 MHz, 438-444 MHz, and 451-457 MHz bands under the umbrella of the MedRadio Service on a
secondary basis for the operation of bandwidth intensive wireless medical devices. We proposed to adopt


6 See Investigation of the Spectrum Requirements for Advanced Medical Technologies, ET Docket Nos. 06-135,
05-213, and 03-92, Report and Order, 24 FCC Rcd 3474 (2009) (MedRadio R&O).
7 Investigation of the Spectrum Requirements for Advanced Medical Technologies, ET Docket Nos. 06-135, 05-213,
03-92, Notice of Proposed Rulemaking, Notice of Inquiry, and Order, 21 FCC Rcd 8164 (2006). In response to this
Notice of Inquiry, AMF filed comments describing its work with implanted microstimulator devices. Comments of
Alfred Mann Foundation, ET Docket No. 06-135, filed Oct. 31, 2006.
8 Petition for Rulemaking, Alfred Mann Foundation, RM-11404, filed September 5, 2007 (AMF Petition).
9
See
Alfred Mann Foundation, Neuromuscular
Disorders, at http://aemf.org/our-research/current-
focus/neuromuscular-disorders/.
10 See Alfred Mann Foundation, Experimental License, Call Sign WD2XLW, issued in 2005 and renewed in 2009.
11 Examples of FES applications include allowing paraplegics to stand, restoring hand grasp function for
quadriplegics, and restoring patient’s bowel and bladder function. FES can also be used for treatment of numerous
debilitating medical conditions that are not responsive to pharmaceutical treatment, such as arthritis, pain, and
migraine headache.
12 See generally Amendment of Parts 2: and 95 of the Commission's Rules to Provide Additional Spectrum for the
Medical Device Radiocommunication Service in the 413-457 MHz band, ET Docket No. 09-36, RM-11404, Notice
of Proposed Rulemaking
, 24 FCC Rcd 3445 (2009) (NPRM). The NPRM followed an October 3, 2007 Public
Notice in which the Commission sought comment on AMF’s petition. Amendment of Parts 2 and 95 of the
Commission's Rules to Establish the Medical Micropower Network Service in the 413-457 MHz band, RM-11404,
Public Notice, Report No. 2835 (Oct. 3, 2007). Commenters responding to the Public Notice had expressed broad
support for the proposal and agreed that AMF’s work could revolutionize the treatment of neurological injuries and
diseases.
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rules that would provide spectrum access for wireless MMNs that would be comprised of multiple
networked implanted devices that employ wideband FES techniques.
9. The Commission received 63 comments and 3 reply comments in response to the NPRM, and
the record was broadly supportive of the MMN concept. For example, a diverse group of 55 commenters
(including members of Congress, universities, the medical community, and veterans associations)
expressed general support for the proposed rules.13 Other commenters, generally representing entities
with license interests in the 413-457 MHz band, objected to allocation of spectrum in the 413-457 MHz
band for MMNs while expressing concern that secondary medical device users would be unable to
successfully co-exist with primary users in the bands.14 While generally supportive of the NPRM’s goals,
the parties are concerned that if the medical devices receive harmful interference from the incumbent
radio services then incumbent users could be asked to modify or downgrade their systems to protect the
health of patients using MMN devices.15 The record also includes detailed testing reports and analysis
commissioned by AMF that examined whether MMN devices could co-exist with incumbent systems in
the 413-457 MHz band.

III.

DISCUSSION

10. The work that AMF has done with the Veterans Administration and other hospitals under its
experimental license has proven the potential benefits of MMNs. We strongly believe that widespread
MMN deployment can foster important advancements in medical care by, for example, significantly
improving the quality of life for the many Americans suffering from spinal cord injuries, traumatic brain
injuries, and strokes.16
However, we also recognize that MMNs represent a new type of radio
communication which does not readily fit into any of the existing spectrum allocations. Because of the
significant benefits that MMNs are poised to deliver, we conclude that the public interest warrants
modifying our rules to allow their use. First, we discuss the characteristics of MMN operations and
conclude that this service is best accommodated by modifying and expanding our existing Part 95
MedRadio rules. Second, we evaluate the frequency allocations necessary to support MMN operations
and provide a secondary allocation in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz
bands for use by MMNs as proposed. This means these devices cannot cause interference to and must
accept interference from stations of a primary service.17 This restriction ensures that the potential for
interference– i.e., the only cost that would be imposed on other parties – is negligible. Finally, we set
forth the service and technical rules that will allow MMNs operating on a secondary basis to share these
bands with incumbent services.
11. Our decision to allow MMNs to share spectrum with existing services supports the
Commission’s commitment to promoting efficient spectrum use to meet growing demand. In the March


13 See e.g., Comments of Injured Marine Semper Fi Fund, ET Docket No. 09-36, filed July 9, 2009; Comments of
Rehabilitation Institute of Chicago, ET Docket No. 09-36, filed July 14, 2009; Comments of Harvard Medical
School, ET Docket No. 09-36, filed Aug. 11, 2009; and Letter from Congressman John F. Kerry, ET Docket No.
09-36, Oct. 14, 2009.
14 See e.g., Comments of ARRL, the National Association for Amateur Radio, ET Docket No. 09-36, filed Aug. 11,
2009, at 7-8 (ARRL Comments); Comments of the Land Mobile Communications Council, ET Docket No. 09-36,
filed Aug. 11, 2009, at, 2, 5 (LMCC Comments); Comments of Engineers for the Integrity of Broadcast Auxiliary
Services Spectrum, ET Docket No. 09-36, filed June 25, 2010, at 3 (EIBASS Comments).
15 See e.g., Comments of the Society of Broadcast Engineers, ET Docket No. 09-36, filed Aug. 11, 2009, at 3-6 (SBE
Comments
).
16 We note that any future MMN equipment will have to undergo an independent testing and approval process by the
Food and Drug Administration (FDA) before being used for medical purposes.
17 See 47 C.F.R. § 2.105(c)(2). The primary uses of this spectrum are discussed infra at paras. 25-27.
4

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2010 National Broadband Plan, the Commission underscored the importance of expanding opportunities
for innovative spectrum access models made possible by advanced technologies.18 The Commission
sought to promote the development of such technologies through its dynamic spectrum use technologies
Notice of Inquiry.19 MMNs, which make use of advanced technology such as spectrum sensing, dynamic
frequency selection, and notching out of interference signals to share spectrum with other services,
demonstrate one such spectrum access model.20 These techniques will allow MMNs to use available
spectrum to provide life-changing health benefits without impairing the ability of other licensed users in
these frequency bands to continue providing service.

A. Medical Micro-Power Networks (MMNs)

12. In the NPRM, we sought comment on authorizing MMN devices to operate in the 413-457
MHz band as an extension of our existing Part 95 MedRadio rules.21 As a Part 95 MedRadio service,
MMNs would qualify for license-by-rule operation22 pursuant to Section 307(e) of the Communications
Act (Act).23 Under this approach, medical devices would operate in the band on a shared, non-exclusive
basis with respect to each other. AMF supports the license-by-rule framework and no one objects to this
approach or suggests alternative licensing methods.24
13. As discussed in the NPRM, we will authorize MMN operations under the existing Part 95
MedRadio rules. For MedRadio devices, the Commission determined that the license-by-rule approach
minimized regulatory procedures and would facilitate more expeditious deployment of new generations of
beneficial wireless medical devices.25 Also, MMNs share many characteristics with devices that operate
in the existing MedRadio service. The core MedRadio band from 402-405 MHz is restricted to
communication between an implanted medical device and an external programmer/controller.26 This is
the same architecture employed for AMF’s MMNs. As with MedRadio implant devices, the MMN
implant devices are sophisticated medical devices that are intended to be deployed by or under the
direction of a duly authorized health care professional.27 The power levels proposed by AMF for MMN


18 See Connecting America: The National Broadband Plan, Federal Communications Commission, March 2010,
Section 5.6, at 94-96.
19 Promoting More Efficient Use of Spectrum Through Dynamic Spectrum Use Technologies, ET Docket No.
10-237, Notice of Inquiry, 25 FCC Rcd 16632 (2010).
20 We will not require MMNs to implement interference mitigation techniques such as automatic power control,
geolocation, etc. because they are designed to be extremely low power devices that operate with a maximum power
of one milliwatt. We expect that future technologies that use dynamic spectrum access techniques may require such
interference mitigation techniques.
21 NPRM at 3445 para. 1.
22 See 47 C.F.R. § 95.1201.
23 Under Section 307(e) of the Act, the Commission may authorize the operation of radio stations by rule without
individual licenses in certain specified radio services when the Commission determines that such authorization
serves the public interest, convenience, and necessity. The services set forth in this provision for which the
Commission may authorize operation by rule include: 1) the Citizens Band Radio Service; 2) the Radio Control
Service; 3) the Aviation Radio Service; and 4) the Maritime Radio Service. See 47 U.S.C. § 307(e)(1).
24 Comments of the Alfred Mann Society, ET Docket No. 09-36, filed Aug. 11, 2009, at 14 (AMF Comments).
25 MedRadio R&O at 3482 para. 25.
26 Body-worn medical devices may also be used in the 402-405 MHz band for a limited patient evaluation period.
MedRadio R&O at 3483-84 para. 32-35.
27 47 C.F.R. § 95.1209; MedRadio R&O at 3485 paras. 37-38.
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devices are on par with the power levels used by MedRadio devices.28 Additionally, both MedRadio
devices and MMN systems are designed to operate in the 400 MHz frequency range, although MMNs
require greater bandwidth than is available under the existing MedRadio rules.29 For the reasons provided
above, we believe that the MedRadio license-by-rule framework is the best way to structure our MMN
rules.
14. Based on the history of this proceeding and the record developed over its course, we find it
appropriate to rely heavily on AMF’s MMN system design when crafting our rules. Although we sought
comment on other types of functional electrical stimulation applications that would be consistent with
MMN operations and that would similarly require the wider emission bandwidths proposed, no
commenter identified other specific applications, devices, or architectures that we should take into
consideration.30 Instead, the record is concentrated on AMF’s specific MMN proposal and research in
this area. The work AMF has performed demonstrates that the benefits that MMNs can deliver are
substantially greater – in both qualitative and quantitative terms – than the developmental and per-patient
deployment costs associated with the rules we adopt.31 Thus, we think it represents the appropriate
starting point for our authorization of this new type of MedRadio service, and it does not appear that
doing so would inhibit the development of additional therapeutic devices for these or similar purposes.
15. Under its experimental license, AMF developed an MMN system that consists of a wireless
network of implantable microstimulators that produce electrical pulses to elicit muscle contractions and
neural responses. The components of this system include an external programmer/controller (P/C) that
coordinates the activities of all other system components;32 separate miniature, battery-powered,
implantable microstimulators capable of sensing body signals or generating stimulation pulses; and a
recharging subsystem consisting of an external charger and coil assemblies.33 Depending upon the nature


28 Under the existing rules, MedRadio devices in the 402-405 MHz band that meet the frequency monitoring
requirements of 47 C.F.R. § 95.628(a) may transmit with a maximum power of 25 microwatts EIRP in a 300 kHz
bandwidth. This would be equivalent to 0.5 milliwatts in a 6 MHz bandwidth, which is on par with the maximum
power levels proposed by AMF. 47 C.F.R. § 95.639(f); AMF Comments Appendix B at 5.
29 See MICS R&O at 21043-44 para. 8.
30 NPRM at 3453 para. 26.
31 See footnote 2, supra. AMF estimates that the costs of providing an initial model of an MMN system (consisting
of a master control unit, or “MCU,” and five to six microstimulator implants) to a patient in compliance with the
proposed rules would total approximately $50,000. AMF expects that these costs will decrease as economies of
scale and scope are achieved. Additionally, it notes that these estimated costs exclude their sunk investment costs,
such as costs attributable to initial research and development of interference mitigation techniques (approximately
$2.2 million) and independent laboratory testing of those techniques (approximately $190,000). See Alfred Mann
Foundation ex parte, ET Docket No. 09-36, filed November 15, 2011 at 2.
32 The P/C is a portable device that may he carried by the patient or placed in a convenient location within a few
meters of the patient. It is the communication and control hub that transmits and receives signals to and from all
implanted devices in the system. Specifically, it coordinates the activity of the implanted devices by receiving
sensing data from the implanted devices, processing that data, and creating a stimulation pattern in the appropriate
implant devices by transmitting instructions based on the processed data to the implanted devices. It also serves as
the basic user interface for the patient, providing system activation, alarms, program selection, and limited parameter
control. AMF Petition at 4 n.1.
33 According to AMF, the charger generates a magnetic field at 127 kHz with the external coil worn only when
recharging the batteries in the implanted devices. The external coil includes a faraday shield to limit emissions
levels in compliance with the FCC emission limits. The P/C communicates with each implant device to determine
which device requires recharging and when a device is fully charged. The recharging subsystem includes a
temperature sensor that halts the recharging process if the external coil temperature were to rise above a
(continued….)
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and extent of the neurological condition, AMF envisions that one to 100 microstimulators would be used
for any given patient, although an average of two to 12 microstimulators is estimated for the typical
patient. Each of the implanted microstimulators is cylindrical and measures approximately 3.4 mm in
diameter and 25 mm long, making them fully implantable into the human body by injection or other
minor surgical procedure. Their small size, however, permits only limited battery power.
16. AMF designed its MMN system to operate on 5 MHz channels in the 413-457 MHz band.
These design choices take advantage of favorable signal propagation in the human body.34 MMNs that
operate on these frequencies, AMF states, can transmit at low power (e.g., less than 1 milliwatt) using the
small batteries that are integral to the implanted microstimulators.35 Additionally, the five megahertz
wide channels allow MMNs to send large amounts of heavily encoded data very quickly.36
17. MMNs must also operate in a congested frequency environment and use a number of
sophisticated techniques to mitigate the harmful effects of interference from incumbent co-channel
services.37 AMF designed its MMN system to occupy only one of the four proposed frequency bands at
any given time. The P/C has the ability to continuously assess the quality of the frequency band and
switch the MMN system to another of the four available bands if necessary, allowing the MMN to make
robust use of the available spectrum and respond to changing spectrum conditions. Additionally, the
wideband nature of the MMN signals will make them less susceptible to interference from narrowband
signals in general, and AMF has specifically designed the P/C to filter out narrowband interference
signals, (i.e. it “notches out” the signals).38 This feature, coupled with the error correction coding
techniques, minimizes system susceptibility to interference from narrowband signals. Additionally,
because MMN transmissions are only a few microseconds long, interference from other short duration
transmissions from incumbent users is less likely to occur.39 In the event that all four bands are unusable
despite the interference mitigation techniques, AMF’s MMN system is designed to enter a “graceful
shutdown” mode to protect the person in whom the devices are implanted.40
18. In the NPRM we sought comment on a number of definitions that AMF proposed be added to
the Part 95 MedRadio Service rules for devices operating in the 413-457 MHz band.41 These definitions
were for a Medical Micropower Network (MMN), MMN control transmitter, MMN implant transmitter,
(Continued from previous page)


predetermined level. Id. at 4 n.2. We presume that the charger functions in a manner similar to chargers used for
MedRadio devices under our previous rules. We emphasize that the charger must operate in compliance with our
rules for Part 18 devices. 47 C.F.R. §§ 18.101-311.
34 Reply Comments of the Alfred Mann Foundation, ET Docket No. 09-36, filed Sept. 10, 2009, at 5-7 (AMF Reply);
See paragraph 24, infra.
35 According to AMF, the small battery size imposes constraints on power consumption, which increases with
operating frequency. AMF Comments at 6.
36 Id. at 8.
37 Id. at 10-13. See also ARRL Comments at 10-12 (discussing how specific elements of AMF’s system design work
to mitigate potential interference from incumbent operations).
38 As AMF notes, implanted devices operate in a lower radiofrequency noise environment due to attenuation by the
human body. Alfred Mann Foundation ex parte, ET Docket No. 09-36, filed Aug. 15, 2011, at 2 (AMF 8/15/11 ex
parte
).
39 As described below, one such Federal Government use in the bands under consideration is for pulse modulated
radar transmissions.
40 Alfred Mann Foundation ex parte, ET Docket No. 09-36, filed June 8, 2011, at 2. The graceful shutdown or fail-
safe mode executes a pre-programmed, customized sequence of actions to allow the implant to operate
independently of the P/C for a brief period. AMF ex parte 8/15/11 at 3.
41 NPRM at 3453-54 para. 30.
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and MMN transmitter. Few commenters addressed these proposals. One of these parties, Mark
Sienkiewicz, suggests that the MMN definition not be specifically limited to FES because research into
biotechnology may discover other uses for implanted medical device networks in the future.42 He also
questions the limitation of MMN transmissions to non-voice data because he thought there might be
medical applications for voice data. Sienkiewicz also asks that the definition of an MMN control
transmitter not be limited to operations outside the body because future devices could become
implantable. The Cleveland FES Center requests that the MMN definition be modified to allow networks
of implants that are not under the control of an MMN control transmitter.43
19. We adopt a single definition for MMN, as follows:
Medical Micropower Network (MMN): An ultra-low power wideband network consisting
of a MedRadio programmer/control transmitter and medical implant transmitters, all of
which transmit or receive non-voice data or related device control commands for the
purpose of facilitating functional electric stimulation, a technique using electric currents to
activate and monitor nerves and muscles.
This definition tracks AMF’s proposal in substance, with some word alterations to be consistent with the
other MedRadio definitions. It is important to make these frequency bands available for medical
applications such as AMF’s MMNs that cannot be accommodated in other frequency bands and to avoid
use of the band by non-medical devices or for non-medical purposes. The definition we adopt
accomplishes this goal. Because the existing MedRadio definitions in Part 95 of our rules for MedRadio
programmer/control transmitter, Medical implant transmitter, and MedRadio transmitter can also describe
the functions of the MMN control transmitter, MMN implant transmitter, and MMN transmitter,
respectively, we will not adopt MMN-specific definitions for these devices.44
20. We decline to adopt the more expansive definitions proposed by Sienkiewicz and the
Cleveland FES Center or to substantially deviate from the framework we proposed in the NPRM. We
recognize that the existing programmer/control transmitter definition does not permit use of implanted
programmer/control transmitters or the deployment of an MMN that functions without a
programmer/control transmitter, as Sienkiewicz and the Cleveland FES Center have suggested should be
permitted for MMNs.45 The record in this proceeding is largely based on AMF’s MMN system, which
uses an external programmer/control transmitter which implements a number of interference mitigation
techniques to allow the MMN to share spectrum with other services in these bands and which has been
subject to extensive testing. We have no information at this time to determine whether an MMN without
an external programmer/controller could mitigate the effects of interference and successfully coexist in
these bands. Other use of these frequency bands such as for non-FES medical applications or allowing
transmission of voice data is speculative at this point.46
No one has provided guidance on what
alternative specifications would appropriately accommodate other uses while not compromising the
potential of MMNs. Further modification to the rules may be readily sought if and when a need arises.


42 Comments of Mark Sienkiewicz, ET Docket No. 09-36, filed July 13, 2009, at 2 (Sienkiewicz Comments).
43 Comments of the Cleveland FES Center, ET Docket No. 09-36, filed Aug. 10, 2009, at 2 (Cleveland FES
Comments
).
44 47 C.F.R. Appendix 1 to Subpart E of Part 95.
45 See Sienkiewicz Comments at 3; Cleveland FES Comments at 2.
46 In the MedRadio preceeding we rejected allowing wireless hearing aids to use the MedRadio band because they
would be expected to operate continuously and therefore would have an increased likelihood of causing interference
to other MedRadio devices. MedRadio R&O at 3486 para. 40. Allowing MMNs to transmit voice data would raise
similar concerns.
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21. Based on this definition and the rules we adopt under it, we can be sure that all MMNs will
be designed with sufficient interference mitigation techniques and design elements to be able to operate
on a secondary basis under our Part 95 Rules. At the same time, and because we want parties to be able
to tap the vast potential MMN technologies have to transform lives and advance the state of medical care,
we reject those comments that would have us bind our rules too tightly to AMF’s specific equipment
design. For example, ARRL urges the Commission not to allow the operation of MMNs or similar
devices with parameters different than the AMF design.47 SBE notes that the only devices addressed in
the NPRM are AMF’s and that other MMN devices may have different interference characteristics.48
Because manufacturers may develop new MMN devices with different interference mitigation techniques,
we do not think it is appropriate to require that all MMN devices function in an identical fashion to
AMF’s devices. Future systems, for example, may rely on technologies that have an even greater
capability to reject interference than AMF’s current design, and we will evaluate individual devices as
part our equipment authorization process.
22. Finally, we sought comment in the NPRM on the service and technical rules that would apply
to medical devices in the 413-457 MHz band. Our discussion generally followed the framework of the
MedRadio Service rules with, for example, modified power and emission bandwidth requirements to
accommodate the proposed MMNs.49 While we did not include a separate appendix of proposed rules,
the NPRM stated that we were seeking comment on allowing additional spectrum to be used under the
MedRadio Service in Part 95 of the Commission’s rules, referenced new rules that AMF had proposed in
its filing, and discussed specific service and technical issues at length.50 For this reason parties have had
ample opportunity to provide meaningful comments on our proposals, and we reject suggestions to the
contrary.51 Because we are including MMNs within the existing framework of the MedRadio Service,
we will apply the existing MedRadio service and technical regulations to MMNs to the extent possible
and only amend the rules in Part 95, Subparts E and I, as necessary to distinguish between MMNs and
other MedRadio devices. As we observed in the NPRM, such an approach “is desirable as it would
maintain consistency with rules applicable to wireless medical devices, particularly for implanted and
related therapeutic devices.” 52

B. Frequency Bands

23. Although we conclude that it is appropriate to license MMNs as a MedRadio service, it does
not follow that it is feasible for MMNs to operate on the existing MedRadio frequencies. This is because
MMNs are different from existing MedRadio applications in important technical and design elements.
For example, a typical MMN is expected to contain multiple implant devices, which will require the
transmission of much more data than the MedRadio devices operating under the existing rules.
Moreover, due to their small size, MMN implant devices must be even more energy efficient than typical
MedRadio implants. This efficiency is achieved by using short transmissions, which necessitate the use


47 ARRL Comments at 15. We note that ARRL is also known as the American Radio Relay League, Incorporated.
Id. at 1.
48 SBE Comments at 2 n.1.
49 NPRM at 3453 para. 27.
50 NPRM at 3445, 3453-59 paras. 1, 27-56.
51 See ARRL Comments at 2 n.1 (suggesting that the Commission did not have sufficient information about MMN
devices to proceed with an NPRM and that the Commission should have published and sought comment on actual
proposed rules); SBE Comments at 2 n.1 (claiming that “[t]hose who wish to comment on specific rules that might
substantially affect the interference potential or interference susceptibility of these devices are precluded from doing
so.”).
52 NPRM at 3453 para 27.
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of much wider bandwidth signals than the 300 kHz currently permitted in the existing MedRadio bands.53
This limit was put in place to maximize the number of medical devices that can use the 5 megahertz
available in the 401-406 MHz band and is consistent with the operational needs of existing MedRadio
applications. By contrast, MMNs are designed to operate with a 5 megahertz emission bandwidth. Thus,
the current MedRadio frequencies are insufficient to support MMN operation.
24. In the NPRM we sought comment on the suitability of four segments of the 413-457 MHz
band for use by MMNs on a secondary basis—i.e., 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-
457 MHz. According to AMF, this band—which is in close proximity to the 401-406 MHz band used by
the MedRadio service—is within the range of frequencies that is most suitable for propagation in the
human body.54 According to AMF, optimal signal propagation within the human body is essential to
allow MMNs to transmit at low power using small batteries and wide bandwidth signals to send large
amounts of data in a short timeframe.
25. The 413-419 MHz band is allocated for Federal fixed, mobile, and space research services
and is used primarily by federal agencies for non-tactical land mobile operations.55 These land mobile
operations include base, mobile, and hand-held portable stations operating on both conventional (single
channel) and trunked (shared multiple channel) systems. The band is heavily used by Federal public
safety agencies. Non-Federal use of this band is limited to fixed stations that transmit hydrological and
meteorological data in cooperation with Federal agencies and may not cause harmful interference to
Federal stations.56
26. The 426-432 MHz and 438-444 MHz bands are allocated for Federal radiolocation services
on a primary basis and for (non-Federal) Amateur services on a secondary basis.57 Radiolocation services
include Federal ground-based, airborne, and shipborne radar systems.58 These radar systems transmit
pulsed signals that may operate on a wide bandwidth over a portion of the band or transmit across the
entire band using spread spectrum frequency hopping techniques. These radar systems are used for very


53 MedRadio R&O at 3488-89 paras. 47-50. An even narrower maximum bandwidth – 100 kHz – is permitted in a 2
megahertz portion of the band.
54 Reply Comments of the Alfred Mann Foundation, ET Docket No. 09-36, filed Sept. 10, 2009, at 5-7 (AMF Reply).
AMF states that tissue tests confirm that frequencies in the lower 400 MHz band are optimal for RF signal
propagation through body tissue. Id. at 6-7. In addition, Medtronic – a manufacturer of implantable MedRadio
devices – has conducted research and analysis that also reaches this conclusion. Id. at 6-7; See also Comments of
Cedric F. Walker, Tulane Univ., ET Docket No. 09-36, filed Aug. 11, 2009.
55 See 47 C.F.R. § 2.106; See also National Telecommunications and Information Administration, Federal Long-
Range Spectrum Plan, at 77 (Sept. 2000) (NTIA Spectrum Plan), http://www.ntia.doc.gov/osmhome/LRSP/Final-
LRSP.pdf.
56 Under footnote US13 of the Table of Frequency Allocations, 12.5 kHz-wide channels within the band are
available for assignment to non-government fixed stations for transmitting hydrological and meteorological data in
cooperation with federal agencies. See 47 C.F.R. § 2.106 n.US13.
57 See 47 C.F.R. § 2.106. Under footnote US230 of the Table of Frequency Allocations, non-government land
mobile radio services are also permitted to operate on certain frequencies within the 422-430 MHz band, but these
operations are limited to areas within 80.5 kilometers (50 miles) of Buffalo, New York; Detroit, Michigan; and
Cleveland, Ohio. See 47 C.F.R. § 2.106 n.US230. Under footnote US269, non-Federal pulse-ranging radiolocation
systems may be authorized along the shoreline of the conterminous United States and Alaska and non-Federal
spread spectrum radiolocation systems may be authorized within the United States and Alaska. These non-Federal
radiolocation systems have secondary status. 47 C.F.R. § 2.106 n.US269. No one has commented on these
radiolocation systems.
58 See NTIA Spectrum Plan, at 77-79. The 426-432 MHz and 438-444 MHz bands also may be used by the military
and the National Aeronautics and Space Administration for telemetry and telecommand. Id.
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long range detection, identification, and tracking of objects and typically employ megawatt transmitters
and high antenna gains resulting in very high equivalent isotropically radiated power (EIRP) levels. The
radar receivers are also extremely sensitive so that they can detect weak returns from targets. In addition,
the Federal Government operates the Enhanced Position Location Reporting System (EPLRS) in these
bands, which is a secure communications network employing a frequency hopping, spread spectrum
method that is used primarily for data distribution and position location and reporting.
27. The 451-457 MHz band is allocated on a primary basis for non-Federal Land Mobile
services. Within this range, the band segments 454-455 MHz and 456-457 MHz also include a primary
allocation for non-Federal Fixed service.59 This band is heavily used by both public safety agencies and
private businesses for private land mobile communications systems.60 These systems use one- and two-
way radio transmissions for coordinating people and materials, dispatching workers and vehicles, and
communicating with first responders. The public mobile service also operates in this band.61 Portions of
the band are also used by the broadcast auxiliary service (BAS) for remote pickup (RPU) stations which
are used to send audio to and from remote locations such as news events or live sporting events and serve
as communication links between radio and TV studios and news crews in the field.
28. Decision. Consistent with our proposal, we will allocate the 24 megahertz of spectrum in
four segments of the 413-457 MHz band for MMN use on a secondary basis, i.e., 413-419 MHz, 426-432
MHz, 438-444 MHz, and 451-457 MHz. As described by AMF, the propagation characteristics of the
400 MHz band make it particularly well suited to host MMN devices, and the band is already used for
other MedRadio implanted devices. Further, because these four band segments will allow for the wide
bandwidth signals required to transmit large amounts of data in a short amount of time, they will provide
the emission bandwidth that MMNs require. As explained below, we do not believe operation on a
secondary basis will detrimentally impact the development or deployment of MMNs as they are designed
to be able to operate on a secondary basis.
29. We also conclude that allocating four band segments for MMN use is necessary to ensure
that an MMN has sufficient spectrum to operate while avoiding causing interference to or receiving
interference from primary users in the band. An MMN will occupy only one band segment at any given
time. By having a variety of authorized frequency bands available and employing protocols that will
allow MMNs to quickly migrate from band to band, an MMN licensee will be able to make robust use of
the available spectrum and respond to changing spectrum conditions. For example, ARRL, in its analysis
of how the MMN channel-switching design can protect patients, states that it is “critical for patient
protection” that we make all four channels identified in the NPRM available for MMN use.62 In addition,
the four band segments serve a mix of Federal and non-Federal use. By permitting MMN use of all four
segments, we will give MMNs more flexibility to operate in differing RF interference environments.
Commenters expressed concern that heavy band use situations could render a particular frequency band
unavailable to MMNs for extended periods of time.63 However, we do not believe that such a possibility


59 See 47 C.F.R. § 2.106. Use of this spectrum is limited by various footnotes to the Table of Allocations to specific
types of operations under Parts 22, 74, 80, and 90 of the Commission’s Rules.
60 Licensed under Part 90 of the Commission’s rules.
61 Licensed under Part 22 of the Commission’s rules.
62 ARRL Comments at 12.
63 The Association of Public-Safety Communications Officers-International (APCO) and Engineers for the Integrity
of the Broadcast Auxiliary Service Spectrum (EIBASS) state that the use of co-channel public safety radios in close
proximity to people with implanted microstimulator devices will result in debilitating levels of interference. See
Comments of the Public-Safety Communications Officers-International, ET Docket No. 09-36, filed Aug. 11, 2009,
at 2-3 (APCO Comments); Engineers for the Integrity of Broadcast Auxiliary Services Spectrum ex parte, ET
Docket No. 09-36, filed May 19, 2011, at 1-2 (EIBASS 5/19/11 ex parte). The Association for Maximum Service
(continued….)
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should categorically preclude us from allocating the four proposed frequency bands. Similarly, the fact
that certain interference mitigation techniques might work in some situations but not in others is not a
reason to prevent MMNs from being authorized to operate in all four frequency bands.64 Even in a worst-
case situation, we can expect that many patients with MMN implants will still be able to make effective
use of at least one of the allocated frequency segments.65
30. We will implement this allocation by modifying footnote US345 to the Table of Allocations
for the MedRadio service to add a secondary mobile, except aeronautical mobile, allocation for the 413-
419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz frequency bands and renumbering this
footnote as US64.66 This allocation will be in addition to the existing allocations in these four frequency
bands and will be limited to use solely by MedRadio operations. We are making this allocation through a
footnote rather than a direct entry in the Table for consistency with the existing MedRadio allocation and
to emphasize the limited nature of this allocation.
31. We will place this footnote in both the Federal Table and non-Federal Table for each of these
four frequency bands to allow use in a variety of settings such as in health care facilities operated by the
Department of Veterans Affairs or the United States military, as well as non-Federal health care
facilities.67 Even though this allocation will be both a Federal and non-Federal allocation, we do not
expect any changes in the primary use of any of these frequency bands. The 413-419 MHz band will
continue to be used primarily for Federal mobile and space research services. The 451-457 MHz band
will continue to be used primarily for non-Federal land mobile services. The 426-432 MHz and 438-444
MHz bands will continue to be shared by the Federal radiolocation service and the non-Federal Amateur
service.68 Because MedRadio use of these bands will be on a secondary basis, MedRadio stations will not
be allowed to cause interference to and must accept interference from primary services sharing the
(Continued from previous page)


Television (MSTV) states that breaking news stories are likely to take place in hospitals and other locations where
individuals with MMNs would be present, thus affecting MMN operations in the 450-456 MHz range. See
Comments of The Association for Maximum Service Television , ET Docket no. 09-36, filed Aug. 11, 2009, at 2
(MSTV Comments).
64 See, e.g., Comments of Motorola Inc., ET Docket No. 09-36, filed Aug. 11, 2009, at 8 (Motorola Comments)
(stating that reducing the MMN bandwidth from 5 MHz to 3 MHz would still likely overlap a large number of land
mobile channels, making it difficult if not impossible for the medical device to find open spectrum).
65 Because MMN devices will operate on one channel at a time, any potential that a particular frequency band will
experience higher levels of interference to MMNs actually bolsters the argument for authorizing MMN operation in
as many channels as practical – including more heavily encumbered ones. Doing so will provide the system with a
wider variety of potential channels in which to operate. Accordingly we allocate for MMN use all 24 megahertz of
spectrum that we identified in the NPRM.
66 The MedRadio band at 401-406 MHz is allocated on a secondary basis to the Mobile, except aeronautical mobile,
service by footnote US345 to the Table. See 47 C.F.R. § 2.106 n.US345. Stations of a secondary service cannot
cause interference to and must accept interference from stations of a primary service, even if the primary service
stations begin operation after the secondary service station has been established. See 47 C.F.R. § 2.105(c)(2). The
new footnote, US64, will apply the provisions of the prior US345 to the 401-406 MHz band while adding provisions
for the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz frequency bands.
67 The Table is further divided into the Federal Table of Frequency Allocations (Federal Table) and the non-Federal
Table of Frequency Allocations (non-Federal Table). The National Telecommunications and Information
Administration (NTIA) authorizes Federal stations in allocations listed in the Federal Table, and the Commission
issues licenses to non-Federal stations in allocations listed in the non-Federal Table.
68 The NTIA and Commission jointly manage shared Federal/non-Federal bands in accordance with a Memorandum
of Understanding (MOU) that governs how rules will be developed and frequency use will be authorized in shared
bands. See Memorandum of Understanding between the Federal Communications Commission and the National
Telecommunications and Information Administration, January 31, 2003, available at
http://hraunfoss.fcc.gov/edocs_public/attachmatch/DOC-230835A2.pdf.
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bands.69 Consequently, there is no reason for any changes to the current coordination procedures between
FCC and NTIA for these frequency bands. NTIA will continue to manage the 413-419 MHz band, the
FCC will continue to manage the 451-457 MHz band, and both agencies will continue to share
management responsibilities of the 426-432 MHz and 438-444 MHz bands.
32. We also note that the spectrum we are adding to the MedRadio Service is allocated to similar
services in both the United States Table and in all regions of the world in the International Table. Thus,
we believe that MMN devices designed to be compatible with U.S. radiocommunications services will be
equally compatible with the services found elsewhere in the world. However, we are not aware of any
other administrations that have made provisions for MMNs. Although individuals using MMNs should
not encounter significantly different electromagnetic environments when traveling abroad, the use of
MMNs may be restricted in other countries.70 We find that the benefits promised by MMNs as well as the
ability for MMNs to coexist with the radiocommunications services already allocated internationally in
the bands under consideration support our decision to adopt the proposed allocation.71
33. We reject other frequency band suggestions made by commenters and find that they would
not be suitable for MMN use. We reject suggestions by the National Association for Amateur Radio
(ARRL), the Land Mobile Communications Council (LMCC), the Enterprise Wireless Alliance (EWA),
and Motorola that the WMTS bands are more appropriate for MMNs.72 In the MedRadio proceeding, the
Commission stated that frequencies below 216 MHz and above 470 MHz are “outside the range of
spectrum generally considered to be the most suitable for propagation of radio signals within the human
body.”73 Because implanted MMN devices must operate with minimal power, efficient propagation of
signals through the human body is extremely important for their operation. The WMTS bands from 608-
614 MHz, 1395-1400 MHz, and 1429-1432 MHz are far above the suitable range for signal propagation
in the human body. While the use of additional power might overcome the decreased propagation of
signals in the human body in these bands as compared to the 400 MHz band, it appears that it is not
practical to substantially increase the size of batteries in the MMN implant devices. In addition, the 608-
614 MHz WMTS band is heavily used in medical facilities and could complicate reliable MMN service in
such close proximity. We therefore conclude that the WMTS bands are not a practical alternative for use
by MMNs.


69 The 426-432 MHz, 438-444 MHz bands are also allocated on a secondary basis to the non-Federal Amateur
service and on a primary basis to the Federal Radiolocation service. Hence these two bands are currently shared
Federal/non-Federal bands. The Amateur service has equal status with MedRadio operations in these bands.
70 We recognize that under the existing allocations, patients with MMN devices potentially would not be able to
operate the devices when traveling internationally. Given that MMNs are expected to, among other things, restore
sensation, mobility, and other functions to paralyzed limbs and organs, we believe that the benefits of MMN use
would far outweigh any potential inconvenience associated with such travel restrictions.
71 We believe that, as U.S. patients begin to realize the benefits of MMNs, there will likely be interest in other parts
of the world where MMNs can bring significant improvements to the quality of life of similarly situated patients.
MMN compatibility with international allocations would be expected to promote the growth of these technologies
globally.
72 ARRL Comments at 15; LMCC Comments at 4-5; Reply Comments of the Enterprise Wireless Alliance, ET
Docket No. 09-36, filed Sept. 10, 2009, at 3 (EWA Reply); Motorola Comments at 9.
73 See MICS R&O at 21042-43 para. 6. ARRL expresses dissatisfaction with AMF’s contention that frequencies
above 470 MHz have unsuitable within-body propagation. ARRL Comments at 5 n.4. However, this contention is
consistent with the Commission’s previous conclusions. See also NPRM at 3451 para. 21 (noting AMF’s
submission that “WMTS spectrum is unsuitable for wideband MMN devices because frequencies above 470 MHz
are outside the preferred range of spectrum for propagation of radiofrequency (“RF”) signals within the human
body.”)
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34. We also do not believe that Motorola’s suggestion that MMNs can use the 902-928 MHz
band is viable given the diminutive size of the implanted MMN devices and corresponding limited
available power. Similar to the WMTS bands, this band is outside the range of frequencies with favorable
propagation characteristics. Motorola suggests that the use of additional power may be able to overcome
the decreased propagation of signals in the human body as compared with the 400 MHz band.74 We do
not find this argument convincing. AMF has conducted tests that show that implanted devices would not
be able to transmit a strong enough signal at 915 MHz to communicate with an external control unit, and
we reject the possible use of larger batteries to produce greater power for the reasons discussed above. 75
35. Parties that object to MMN operations in the 413-457 MHz band focus mostly on the
potential for interference between MMNs and incumbent services. Some parties also question whether
MMNs should be authorized on a secondary basis in this or any band since a secondary service must not
cause interference to primary users and must accept interference from primary users. We address these
concerns below.
36. Our NPRM envisioned, and AMF has designed, MMNs that are capable of operating on a
secondary basis in frequency bands with existing, established incumbent use. Through the use of harmful
interference mitigation techniques, operations on multiple frequency bands, and pre-established shutdown
protocols in the event that no frequency bands are available, MMNs will be able to operate successfully in
the lower 400 MHz band.76 We are further encouraged by the fact that the MMN concept is not just
theoretical: AMF has engaged in prototype development under an experimental license that it has held
since January 200577 and in actual evaluation and testing in cooperation with Federal stakeholders. AMF
notes that it has developed prototype programmer/controllers that implement these interference mitigation
techniques and points out that these techniques have been independently tested and shown to be effective
against a wide range of potential interference signals.78
37. On April 8, 2011, AMF submitted interference analyses, test reports, and technical studies
that it had commissioned to evaluate MMN use in the identified bands.79 These materials were the


74 Motorola Comments at 9-10. Motorola makes this same suggestion regarding the 608-614 MHz WMTS band
which we reject for the same reason.
75 AMF Reply at 7; See also Richard Scanlon, Brian Burns, and Noel E. Evans, Radiowave Propagation from a
Tissue-Implanted Source at 418 MHz and 916.5 MHz
, 47 IEEE Transactions of Biomedical Engineering, 527-34,
533 (April 2000) (concluding that the propagation of signals in the body are expected to be 6 dB worse at 916 MHz
as compared with 418 MHz); A. Alomainy, Y. Hao, Y. Yuan, Y. Liu, Modeling and Characterization of Radio
Propagation from Wireless Implants at Different Frequencies
, Proceedings of the 9th European Conference on
Wireless Technology, 199-122 (2006) (illustrating the differences in within-body propagation loss between 402
MHz, 868 MHz, and 2.4 GHz).
76 AMF Reply at 14; Alfred Mann Foundation ex parte, ET Docket No. 09-36, filed June 8, 2011, at 2 (AMF 6/8/11
ex parte
); AMF Comments at 10-13. EIBASS claims that many of these techniques are not effective since they are
only implemented in the P/C and not the implanted MMN devices. Engineers for the Integrity of Broadcast
Auxiliary Services Spectrum ex parte, ET Docket No. 09-36, filed May 19, 2011, at 5 (EIBASS 5/19/11 ex parte).
AMF responds that implant devices operate in a lower interference environment because of shielding by the human
body and, consequently, the Commission’s MedRadio rules require interference mitigation capabilities only in the
P/C, not the implants. Alfred Mann Foundation ex parte, ET Docket No. 09-36, filed Aug. 15, 2011, at 2 (AMF
8/15/11 ex parte
).
77 AMF Comments at 3-4.
78 Alfred Mann Foundation ex parte, ET Docket No. 09-36, filed July, 7 2011, at 1-2 (AMF 7/7/11 ex parte). The
results of these tests are described in para. 40, infra.
79 Alfred Mann Foundation ex parte, ET Docket No. 09-36, filed April 8, 2011 (AMF 4/8/11 ex parte);
Electromagnetic Compatibilty Analysis of the Alfred Mann Foundation Medical Microprocessor Network, Defense
Information Systems Agency, Joint Spectrum Center, Jan. 6, 2011, ET Docket No. 09-36, filed by AMF on April 8,
(continued….)
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product of a process that began in August 2009, when AMF and the Joint Spectrum Center (JSC) (a field
office within the U.S. Defense Spectrum Organization that provides spectrum planning and support for
U.S. military interests) entered into a memorandum of agreement (MOA) for JSC to conduct a technical
analysis to determine whether MMN devices could co-exist with incumbent government systems in the
413-457 MHz band. As background, NTIA had filed comments in response to the NPRM questioning
whether there would be electromagnetic compatibility issues associated with the proposed MMN devices
and current and future federal systems operating in the band and suggesting that coordinated measurement
efforts with the incumbent federal spectrum users would be necessary.80
38. Pursuant to the MOA, JSC directed a contractor, ITT, to collect, validate, and evaluate
technical data regarding MMN devices and incumbent government systems. The resulting report (JSC
Report) contained a theoretical analysis to evaluate the electromagnetic compatibility (EMC) of
incumbent government system receivers in the presence of radiofrequency (RF) emissions from MMN
transmitters and the EMC of MMN receivers of both the programmer/controller (P/C) and implanted
microstimulator devices— in the presence of RF emissions from incumbent systems.81 The JSC reviewed
the report and approved it for publication in October 2010.
39. The JSC Report concluded that, with respect to the MMN-to-government system interference
potential, (1) “relatively small [required separation distances] result from the low EIRP and duty cycle of
the MMN transmitters combined with the low antenna heights of the MMN,” and (2) MMN systems
“should be operationally compatible and not cause unacceptable interference into [incumbent
government] systems currently authorized to operate in the 410-450 MHz band.”82
40. In addition, AMF commissioned Aerospace Corporation (the operator of a federally funded
research and development center and provider of comprehensive technical service to national security
space programs) to conduct laboratory tests to determine whether MMNs could successfully operate in
the presence of incumbent users.83 To evaluate the performance of the MMN network in the 413-457
MHz band, the Aerospace testers conducted a wired simulation of the frequency bands.84 Specifically
they tested signals representing Federal mobile radio (data and voice), radar (ground and airborne), and
the Enhanced Position Location Reporting System, as well as non-Federal amateur television.85 The tests
specifically targeted four MMN interference mitigation techniques: spectral excising of narrowband
(Continued from previous page)


2011 (JSC Report); Alfred Mann Foundation (AMF) Medical Micropower Network (MMN) Wired Test Report,
Aerospace Corp., Nov. 3, 2010, ET Docket No. 09-36, filed by AMF on April 8, 2011 (Aerospace Report); ITT
Corp. Memorandum, March 1, 2011, ET Docket No. 09-36, filed by AMF on April 8, 2011 (IIT Memo).
80 National Telecommunications Information Administration, ET Docket No. 09-36, filed March 25, 2009, 1, 11.
81 The EMC analysis was performed by establishing interference criteria for both MMN and incumbent systems for
testing purposes and then calculating the required separation distances (RSD) predicted to preclude the potential for
harmful interference between MMNs and incumbent systems. JSC Report at 1-2.
82 JSC Report at 27.
83 See also Aerospace Report at 15, 20, 27, 28 (listing the specific test objectives).
84 In this project, they performed an initial study that used documentation from the National Telecommunications
and Information Administration (NTIA) and the Telecommunications Industry Association (TIA) as a reference to
evaluate signals present in this band. Aerospace Report at 4. They digitally generated all of the signals used for the
MMN evaluation in a personal computer using Matlab®. They then uploaded the signals to a pair of arbitrary
waveform generators (AWG) and up-converted them to the system’s carrier frequency. This methodology enabled
the generation of a large number of different signals within the bands of interest. The study used one signal
generator to inject MMN signals into the frequency band being tested and a second AWG to simulate interferers on
the other three available frequency bands within the bands of interest.
85 Aerospace Report at 13-14.
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incumbent signals; changing frequency bands without suspending critical functions; shutting down in a
communication link loss scenario; and incumbent signal level sensing to avoid interference. The resulting
report (Aerospace Report) concluded that the AMF MMN System performs according to its specifications
and can successfully operate in presence of incumbent users.
41. In conjunction with the Aerospace Report, AMF provided the JSC with an internal AMF
engineering test report entitled “Uplink Path Loss of Four-Wire Antenna Connection in Simulated
FEBPM Implant,” as well as other AMF technical documents describing additional test results and MMN
technical and operational characteristics.86
Together, these documents were responsive to the JSC
Report’s recommendation that testing be conducted to determine the effectiveness of MMN interference
mitigation techniques and to validate the body loss calculations used in the analysis. ITT evaluated
AMF’s additional submissions for the JSC and determined that the Aerospace Report adequately
demonstrated the effectiveness of MMN interference mitigation techniques; that AMF’s tests validate the
body loss measurements that were used in the analysis and were adequate; and that the documents,
collectively, offered additional substantiation of the electromagnetic compatibility results reported in the
JSC Report.87
42. The JSC Report and Aerospace Report offer detailed evaluations of specific interference
scenarios involving a broad spectrum of incumbent operations backed up by testing with actual
equipment. Based on these reports, we conclude that the record demonstrates that MMNs can operate on
a compatible secondary basis with primary Federal operations in the 413-419 MHz, 426-432 MHz, and
438-444 MHz band segments.
43. We are also convinced that MMNs can operate on a compatible secondary basis with
primary non-Federal operations. The findings of the JSC Report, which focused on Federal systems, and
the simulations conducted by AMF and the Aerospace Corporation, which looked at a wider variety of
high-powered signals, support this conclusion. In this regard, non-Federal fixed and land mobile radio
systems in the 451-457 MHz frequency band use the same technologies as Federal fixed and land mobile
radio systems in the 420-450 MHz frequency band.88 Moreover, the mitigation techniques that the
Aerospace Report examined have broad applicability. For example a P/C that incorporates “notching”
techniques could filter out a 100 kHz RPU signal from a BAS operator.89
44. Many parties stated that additional testing would be needed to determine whether MMNs
could operate in conjunction with high power, co-channel incumbent operations.90 We believe that the


86 Alfred Mann Foundation, ET Docket No. 09-36, filed April 8, 2011 at 51 (filed in same document as the
Aerospace Report).
87 IIT Memo at 4-5.
88 See AMF 4/8/11 ex parte at 4. (stating that “most of these non-government systems are virtually identical to their
government counterparts and are supplied from the same manufacturers”); LMCC Comments at 3 (stating that “land
mobile technology in these NTIA bands is similar to that used in the 451-457 MHz band”). Notably, Motorola,
which supplies land mobile radio equipment to both Federal and non-Federal users, does not make it clear in its
comments whether it is discussing one or both types of users when it claims land mobile use is incompatible with
MMNs. Motorola Comments at 2-9.
89 RPU signals in the 451-457 MHz band are, at a maximum, 100 kHz wide. Many RPU signals may actually have
smaller bandwidth. 47 C.F.R. § 74.402(b)-(d). ARRL, in its comments analyzing the AMF system, notes that the
MMN filters are designed to implement numerous notches, up to 250 kHz each, within a particular channel. ARRL
Comments
at 11.
90 SBE Comments at 3, 7 (claiming that, based on the information that was available at the time of its filing, it was
unlikely that MMNs will be able to operate without endangering patients); ARRL Comments at 10 (stating that no
rules for MMN devices should be enacted without a comprehensive series of field tests that assure patient safety in
the presence of typical RF fields in the bands under consideration); EWA Reply at 2 (suggesting that not enough
(continued….)
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JSC Report, Aerospace Report, and associated materials filed by AMF are responsive to these concerns.91
In addition, because these materials provide extensive technical details about the interference mitigation
techniques employed by AMF’s MMN devices,92 we disagree with the contention of the Engineers for the
Integrity of the Broadcast Auxiliary Service Spectrum (EIBASS) that AMF has provided insufficient
technical details about its interference mitigating protocols.93
45. A number of parties claim that incumbent operators could receive harmful interference from
MMN devices. Motorola, for example, claims that AMF’s interference calculations show an
unacceptably high level of interference to land mobile systems in the 451-457 MHz band.94 We disagree.
Several factors serve to reduce any risk that MMNs could cause harmful interference. First, the JSC
Report concluded that the MMN systems would not cause unacceptable interference into government
systems in the 413-419 MHz, 426-432 MHz, and 438-444 MHz bands.95 Again, because the non-Federal
land mobile systems in the 451-457 MHz are virtually identical to the types of government systems
considered in the JSC Report, there is no basis for us to expect interference to non-Federal land mobile
systems.96 Such non-Federal land mobile systems must overcome interference caused by the high-
powered operations of other incumbents in the band. For this reason, they are well equipped to tolerate
the presence of any signals they might receive from an MMN system operating at a much lower power.97
The Aerospace Report, which tested actual prototype MMN devices and concluded that incumbent
services would not receive significant interference, further bolsters our conclusion.98 We further note that
(Continued from previous page)


work had been done to determine whether the 451-457 MHz band satisfies the non-interference criterion necessary
for secondary MMN operations); LMCC Comments at 5 (suggesting extensive testing should be done before
allowing MMNs in 451-457 MHz band); See also Motorola Comments at 3 (stating that each of the four proposed
band segments present “significant challenges” for MMNs to either avoid receiving interference from or preventing
interference to incumbent services).
91 Our analysis focuses on the technical feasibility of deploying MMN systems and, to a lesser extent, the broad
public interest in advancing the state of medical technologies that use the public airwaves. Additionally, MMN
equipment will have to undergo an independent testing and approval process.
92 Aerospace Report at 1-2, 15-17, 20, 23, 27-28; JSC Report at 5-8, 10-12, 23-25.
93 Engineers for the Integrity of Broadcast Auxiliary Services Spectrum ex parte, ET Docket No. 09-36, filed Aug.
26, 2010, at 3 (EIBASS 8/26/10 ex parte) (arguing that AMF has “not discussed at length the technical details of its
claimed interference mitigating protocols” and that “AMF has made sweeping claims about dynamic channel
switching, spectral exclusion/notching, and “signal coding” but has offered no technical details to back up its
claims”) See also SBE Comments at 8.
94 Motorola Comments at 6-9. Motorola also argues that a number of erroneous assumptions that AMF made in its
calculations mean that the actual interference levels will be even higher. AMF has responded that the calculations it
submitted in the petition were an extremely conservative worst-case scenario based on free-space loss that does not
take into account other factors that would result in greater losses, the JSC Report uses an alternate approach, and
Motorola’s analysis is fatally flawed. AMF Reply at 11-13. See also APCO Comments at 2 (recommending further
testing to ensure that MMN devices do not cause interference to public safety radios).
95 JSC Report at 27.
96 Motorola’s concerns were based on the analysis submitted with AMF’s petition. We believe that the JSC Report
offers a more detailed and accurate interference analysis and therefore serves as a more appropriate frame of
reference. Motorola has not commented on the JSC report or AMF’s associated filings.
97 We are permitting MMN devices, whether programmer/controllers or implanted devices, to transmit at a
maximum output power level of one milliwatt. In comparison, the output power levels of land mobile systems in the
413-419 MHz and 451-457 MHz bands are typically 10 to 90 watts and radar systems in the 426-432 MHz and 438-
444 MHz bands are typically 1 to 5 megawatts. National Telecommunications and Information Administration ex
parte
, ET Docket No. 09-36, filed March 25, 2009, at 2-4.
98 Aerospace Report at 3, 13-31.
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some commenters have rejected the likelihood of interference from MMN devices to their services which,
like land mobile systems, operate at much higher powers than MMNs.99 Finally, we adopt service rules
that will require an MMN to switch to another frequency if it appears that there is an incumbent operating
in close proximity.100
46. A second concern for many commenters is whether MMNs will be able to tolerate the
interference caused by non-Federal operations in the bands. This is because, as secondary users, MMN
licensees must be prepared to accept any interference received from incumbent operations. The
Enterprise Wireless Alliance, the Land Mobile Communications Council (LMCC), and Motorola all state
that high-power land mobile transmitters that are heavily deployed throughout the 451-457 MHz band are
likely to interfere with MMN device operation.101 APCO points out that public safety organization use of
the 426-430 MHz spectrum for portable and mobile communications may interfere with MMN use of the
spectrum in some areas.102 The Society of Broadcast Engineers (SBE), the Association for Maximum
Service Television (MSTV), and EIBASS claim that use of portions of the 451-457 MHz band by BAS
remote pick-up operation (RPU) would prevent MMN operation.103
47. As discussed above, the studies commissioned by AMF show that MMNs are able to
function with a significant amount of interference from incumbent operations.104 As such, we are not
persuaded by those comments that claim that MMNs are incompatible with incumbent non-Government
licensees. Incumbent systems that operate in the bands under consideration share the same high-powered
operational attributes that MMNs have been specifically designed to tolerate.105
48. To the extent that these objections focus on the fact that a transmitter of a particular service
may cause interference when operating in close proximity to an MMN device, commenters fail to
acknowledge that the MMN system design anticipates such a scenario. There is no dispute that MMN
devices may not be able to function in one or more of the four bands at a particular moment because of
interference. AMF’s MMN devices are capable of switching among the four different bands and are
designed to operate on one band at a time, and the Aerospace Report found that this design feature
worked as planned.106 Moreover, because MMNs are designed to operate in a variety of bands with a


99 ARRL Comments at 2; EIBASS 5/19/11 ex parte at 1 (concluding that MMN devices are unlikely to cause
interference to amateur operations and RPU BAS operations, respectively).
100 See paragraph 60, infra.
101 EWA Reply at 4; LMCC Comments at 4; Motorola Comments at 3-4.
102 APCO Comments at 2; See also LMCC Comments at 3 (noting that non-Federal licensees use the 426-430 MHz
spectrum).
103 The 450-451 MHz and 455-456 MHz spectrum is used by BAS Remote Pickup stations under Part 74, Subpart D
of the Commissions rules. SBE Comments at 5; MSTV Comments at 2; Comments of Thomas R. Spencer, ET
Docket 09-36, filed March 24, 2009 ( Spencer Comments); Comments of Engineers for the Integrity of Broadcast
Auxiliary Services Spectrum, ET Docket No. 09-36, filed June 25, 2010, at 3 (EIBASS Comments).
104 ITT Memo at 3-5.
105 Some commenters may not fully understand the nature and characteristics of implanted medical radio devices.
For example, EIBASS claims that many of the interference techniques used by AMF’s MMNs are not effective
since they are only implemented in the P/C and not the implanted MMN devices. EIBASS 5/19/11 ex parte at 5.
AMF responds that implant devices operate in a lower interference environment because of shielding by the human
body, and consequently, the Commission’s MedRadio rules require interference mitigation capabilities only in the
P/C, not the implants. Alfred Mann Foundation ex parte, ET Docket No. 09-36, filed Aug. 15, 2011, at 2. We agree
and see no reason to deviate from the existing MedRadio rules.
106 SBE notes that the only devices addressed in the NPRM are AMF’s and that other MMN devices may have
different interference characteristics. SBE Comments at 2 n.1. The testing AMF has done illustrates that it is
possible to build MMN devices that have a high degree of interference immunity in these bands.
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diverse set of Government and non-Government users, a band that is rarely available for use in a
particular place or at a specific time may be uncongested in other situations.107 Under this reasoning, we
are not troubled by EIBASS’s claim that the tests submitted by AMF did not specifically consider RPU
operations, a claim AMF refutes.108 EIBASS states that RPU broadcasts are distinct because they often
employ a long duty cycle and postulates a scenario where extended RPU operations would take place at a
health care facility.109 In such a case, the MMNs operating in that place and time would simply not be
able to access the portion of the MedRadio band that is being used by the RPU operator.
49. Several parties argue that it would be inappropriate for us to permit medical devices—and
MMNs in particular—to operate on a secondary basis.110 Parties raise variations of this issue in their
comments. For example, Motorola cautions against relying on secondary status and asks whether
abnormal operation of the devices due to interference could negatively affect patients, while MSTV warns
that there may be unintended negative consequences from allowing medical devices to use spectrum used
on a primary basis by other services.111 EIBASS, which strongly asserts that secondary medical operation
is an inappropriate policy, takes the position that “[i]f the application is for an important medical purpose,
then the use of RF spectrum for that purpose needs to be on a primary, protected, basis.”112 It also claims


107 See paragraph 29, supra; See also ARRL Comments at 5-6 (claiming that amateur radio television transmitters
would cause interference on par with what MMNs would experience in the 450-470 MHz band, a band AMF has
rejected due to interference concerns). Even if amateur television operations are similar to the types of operations
that led AMF to not pursue the use of frequencies above 457 MHz, it does not automatically follow that such
operations are so pervasive as to raise the same level of interference concerns for successful MMN operation.
108 Engineers for the Integrity of Broadcast Auxiliary Services Spectrum ex parte, ET Docket No. 09-36, filed July
15, 2011, at 1 (EIBASS 7/15/11 ex parte); See also Society of Broadcast Engineers ex parte, ET Docket No. 09-36,
filed June 17, 2011, at 1; Alfred Mann Foundation ex parte, ET Docket No. 09-36, filed Aug. 15, 2011 at 1-2. We
also discuss paragraph 43, supra how MMNs can mitigate interference with BAS RPUs.
109 EIBASS 7/15/11 ex parte at 2 (discussing a remote broadcast in support of a “Jump Rope for Health” or similar
fundraising event taking place in a hospital setting). EIBASS also points out that the AMF website contains a
section called “commercializing your idea” to indicate AMF has a profit motive for developing the MMN
technology. See Engineers for the Integrity of Broadcast Auxiliary Services Spectrum ex parte, ET Docket No. 09-
36, filed June 25, 2010 at 1. We do not see how this relates to the technical arguments under consideration here.
110 Commenters offer two examples to illustrate why secondary status for medical devices is not appropriate. Prior to
2000, WMTS operations in the 450-470 MHz band operated on a secondary basis under Part 90 to primary land
mobile operations. The Commission decided to cease authorizing WMTS operations in this band because of
interference concerns and allocated spectrum elsewhere for WMTS. Because the incumbent operations in 451-457
MHz that we are designating for MMNs are the same as in the 460-470 MHz band previously used by WMTS,
LMCC argues that the Commission should prevent MMNs from operating in the band to avoid a similar situation in
the future. See LMCC Comments at 4-5. Other commenters point to interference that WMTS devices experienced
from television stations during the digital television transition, when some wireless medical telemetry devices
operating on an unlicensed basis on the television bands experienced disabling interference in conjunction with the
launch of new digital stations operating on previously unused channels. See SBE Comments at 6. We note that,
unlike WMTS, MMN devices will be frequency agile and can avoid interference situations in this band. In the case
of wireless telemetry operation in the television bands, the expectation that no television stations would operate on a
co-channel basis with medical telemetry devices was upset by the digital television transition. Moreover, none of
the bands identified for MMN use contain a broadcasting allocation or are used for over-the-air television
broadcasting.
111 Motorola Comments at 5; MSTV Comments at 1; See also ARRL Comments at 7 (stating that Amateur operators
have a “practical inability” to protect patients with MMN implants); Spencer Comments at 1 (questioning the
viability of any medical device “which much be 100 percent reliable under any conditions” under the proposed
secondary allocation).
112 Engineers for the Integrity of Broadcast Auxiliary Services Spectrum ex parte, ET Docket No. 09-36, filed Aug.
26, 2010, at 4-5.
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that patients can potentially be put at risk if the MMN devices must shut down because they cannot
communicate because of interference.113
50. We disagree with parties that argue that we should never allocate spectrum to medical
devices on a secondary basis. As a general matter, we take many factors into account in deciding whether
a given service should operate with a primary or secondary status in a designated frequency band or even
whether a device should operate on an unlicensed basis under Part 15 of our rules. Each case is evaluated
on its own merits. This is also true of our allocations for medical devices. At the present time, the
Commission’s rules allow medical devices to operate on a primary basis, on a secondary basis, and on an
unlicensed basis.114 We find in this order that the characteristics of the MMN devices at issue here
warrant operation on a secondary basis. The MMN devices that will be deployed under the rules that we
adopt herein will be frequency agile and can switch to other frequency bands when interference occurs.
Thus, the MMN devices will be designed with capabilities that enable them to share spectrum with
primary services successfully. Rigorous testing has shown that MMN devices can perform as intended.
51. We acknowledge that there may be instances when MMN devices cannot operate due to
interference on all frequency bands. However, we also note that AMF has accounted for this possibility
by designing its MMN devices to shut down in a controlled, pre-planned manner that is designed to avoid
harm to the patient or others if interference in all four frequency bands prevents successful reception of
signals by the MMN system.115 We reject the notion that the potential for such a shutdown should
categorically bar us from designating spectrum for MMNs and, thus, deny the benefits associated with
these devices.116 The Food and Drug Administration (FDA), as part of its independent review process,


113 EIBASS 5/19/11ex parte at 3; EIBASS 7/15/11 ex parte at 3. EIBASS also claims that a 2010 Order on
Reconsideration
that refused to allow secondary use of the 1.427-1.432 GHz band for WMTS implies that secondary
use of the 451-457 MHz band for MMNs should not be allowed. Engineers for the Integrity of Broadcast Auxiliary
Services Spectrum ex parte, ET Docket No. 09-36, filed May 14, 2010, at 1-3 (EIBASS 5/14/10 ex parte) (see
Amendment of Part 90 of the Commission’s Rules, WP Docket No. 07-100, Order on Reconsideration, 25 FCC Rcd
5105 (2010) (WMTS Recon Order)). However, that order clearly states that secondary WMTS was not being
permitted in the band because the record there did not reflect that it is possible to develop appropriate and effective
measures to detect and avoid harmful interference. WMTS Recon Order at 5106 para. 4. That is not the case here.
Furthermore, the WMTS Recon Order clearly states that it applies only to WMTS, takes into account the unique
technical characteristics of the service, the lack of safeguards in our rules to promote safe secondary operations, and
the operations with which WMTS shares spectrum. Id.
114 For example, WMTS operates on a primary basis and MedRadio operates on a secondary basis. For recent
examples of unlicensed wireless medical devices see, for example, Boston Scientific Corp., Request for Waiver of
Section 15.205 of the Commission’s Rules to Permit the Marketing and Operation of Certain Medical
Communications Devices that Operate in the 90-110 kHz band, ET Dkt. No. 05-331, Order, DA 11-1427, 26 FCC
Rcd 11405 (2011) (waiver of Part 15 rule to allow marketing and unlicensed operation of implanted cardiac devices
in restricted bands); Letter to Mitchell Lazarus from Julius P. Knapp, Chief, Office of Engineering and Technology,
DA 09-2425, 24 FCC Rcd 13795 (2009) (waiver of Part 15 emission limits to permit the marketing and unlicensed
operation of an implanted device in the 6.78 MHz band used for treating gastro-intestinal disorders); Office of
Engineering and Technology Declares the Second Sight Medical Products Inc. Request for Waiver of Rule Section
15.209(a) to be a “Permit-but-Disclose” Proceeding for Ex Parte Purposes and Request Comment, ET Docket 11-
123, Public Notice, 26 FCC Rcd 10286 (2011) (pending waiver for a retina prosthesis system for unlicensed
operation under Part 15).
115 AMF 8/15/11 ex parte at 3. See also ARRL Comments at 12 (describing how the implants are designed to
“function in such a way as to permit the neuron triggering on a low-level basis that apparently allows, for example,
limb movement”).
116 Furthermore, we do not consider such a shutdown to be a “malfunction,” as EIBASS suggests. See EIBASS
Comments
at 2. We also reject EIBASS’s inference that it is not in the public interest to authorize a medical implant
device unless it is able to deliver active therapy at all times in all cases. Therapeutic needs vary greatly between
(continued….)
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will take into account these “graceful shutdowns” when it determines when and how MMN use can be
prescribed. Further, we will require that MMN devices be authorized under the direction of a duly
authorized health care professional who will inform patients of the risks associated with MMN use,
including “graceful shutdowns.”
52. We must balance the cost of allowing MMNs to operate on a secondary basis in these bands
against the benefits that patients could potentially receive from their use. Given the extremely low risk of
incumbent services suffering interference from MMNs and the yet lower risk of a harmful result from any
such interference, the potential benefits of establishing a secondary allocation and adopting rules to allow
MMN operation outweigh the slight risk to incumbent services. Because of the great potential of MMNs
to improve the lives of people who suffer from a range of illnesses such as spinal cord injuries, traumatic
brain injuries, strokes, and various neuromusculoskeletal disorders, we recognize the enormous potential
benefit of allowing MMNs to become a reality. The benefits of making this secondary allocation and
adopting rules to facilitate MMN operations therefore far exceed any potential costs.
53. Lastly, we address several commenters’ overarching concerns that new MedRadio
applications must remain truly secondary – neither interfering with incumbent operations nor creating an
expectation that MMNs must be protected from the types of interference that higher-powered primary
uses may legitimately cause. For example, EIBASS claims that when medical devices operating on a
secondary basis receive interference from a primary user, the primary user is likely to receive the blame
and have to take action to protect the medical device.117 We fully intend that MMN devices will operate
within the constraints of their secondary status, and we do not adopt here any limitations on the
operations of incumbent primary services in these bands for the benefit of MMN operation. Because
AMF has designed its MMNs to anticipate interference and to operate in a challenging spectrum
environment, we are confident that they will remain secondary in both rule and practice.118 We also
clarify that MMNs, the Amateur Radio Service, and the non-Federal radiolocation service — all of which
operate under a secondary allocation in the 426-432 MHz and 438-444 MHz bands—will have equal
status.119 Given that MMN devices are expected to implement measures to mitigate the effects of
interference, it is reasonable to expect the MMN devices to tolerate some interference from the Amateur
Service or to move to another frequency band as needed. As ARRL concedes, MMN devices are
“unlikely generally” to cause interference to Amateur Radio communications in these bands.120

C. Service and Technical Rules

54. In the NPRM the Commission asked about the service and technical rules that should apply
to medical devices in the 413-457 MHz band. The discussion generally followed the framework of the
existing MedRadio Service rules and proposed to modify specific rules, such as those pertaining to power
and emission bandwidth requirements, to accommodate the proposed MMNs. The Commission also
noted that the service and technical rules discussed in the NPRM were essentially consistent with
recommendations made in the Alfred Mann petition.
55. We adopt the overall approach proposed in the NPRM. Thus, rather than creating a new rule
subpart for MMNs, we will only amend the service and technical rules contained in Part 95 Subparts E
(Continued from previous page)


patients and between therapies and efficacy is best evaluated by the FDA. Such an absolute standard would curtail
the deployment of MMNs, as well of many other beneficial medical applications.
117 EIBASS Comments at 4; See also SBE Comments at 3.
118 The rules we adopt specifically require that MedRadio programmer/control transmitters shall have the ability to
operate in the presence of other primary and secondary users. See Appendix A rule Section 95.628(d), infra.
119 47 C.F.R. § 2.106.
120 ARRL Comments at 8.
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and I of our rules to the extent necessary. We also adopt service and technical rules that are based on the
research undertaken for AMF’s MMN devices. This approach offers incumbent operators greater
certainty as to the types and characteristics of MedRadio devices that may be deployed in the band and,
because it is backed by extensive testing, provides greater certainly that MMNs and other new medical
technologies will be able to thrive on a secondary basis in these frequencies. We are confident that the
state of medical radiocommunication technology will evolve and improve over time, as will mitigation
techniques that maximize sharing potential on a secondary basis. Further development and testing of
future generations of MMNs may allow us to adopt service rules that provide even greater flexibility
while still protecting incumbent services. However, the service and technical rules we adopt here are
appropriate based on the record before us today.
56. Interference Mitigation. Because MMNs will operate under the secondary MedRadio
Service, they must be designed to function in the presence of signals from other services operating in the
same frequency bands. The interference analysis, test reports, and technical studies that AMF submitted
have demonstrated that it is possible to build MMNs that are highly resistant to interference, and as
technology continues to advance, we believe it will be possible to build MMN devices that are even more
capable of functioning in the presence of interference. To ensure future flexibility for equipment
designers, we will not require that MMNs include all of the types of interference mitigation techniques
that AMF has employed in its MMN devices. Instead, we will adopt the general requirement that P/C
transmitters have the ability to operate in the presence of other users in the 413-457 MHz band, and we
will incorporate several basic interference mitigation provisions into our rules. We expect that MMN
technology developed in the future will be at least as capable of co-existing with other services as the
system AMF has demonstrated.
57. Regardless of the interference mitigation techniques employed, we expect that there will be
instances where MMNs will not be able to function in a particular frequency band because of a high level
of interference from other stations. To provide a greater probability that an MMN will continue to
function in the presence of interference, we adopt the requirement that all MMNs be capable of operating
in any of the four frequency bands and that they be able to switch to another frequency band when the
band on which they are operating becomes unavailable due to interference. We conclude that these
requirements will not increase the cost of equipment unreasonably or be burdensome for manufacturers to
meet. As AMF has noted, these four bands are nearly adjacent in frequency and thus incorporation of a
multi-channel operating capability requires no significant change in antenna or transmitter design and
“imposes no undue economic burden.”121 Only a single transmitter and one antenna are necessary to
cover these four bands. Components to enable manufacturers of MMNs to meet this requirement should
be readily available since equipment is currently designed to operate across the Federal mobile bands
between 406.1 MHz and 450 MHz and non-Federal mobile bands between 450 MHz and 512 MHz.122
Thus, we conclude that the improved robustness of MMNs that will result from these requirements will
more than offset the expected minimal cost of implementing them.
58. We also note that AMF has proposed several rules regarding interference mitigation
techniques for MMNs.123 These suggested rules are based on AMF’s experience in building and testing
MMN systems. Because of AMF’s expertise in this area and the lack of input from other parties on this
issue, we are adopting technical provisions to add assurance that any MMN technology developed in the
future will be able to operate successfully in the heavily used 413-457 MHz frequency range.


121 See Alfred Mann Foundation ex parte, ET Docket No. 09-36, filed Nov. 15, 2011 at 2.
122 A staff search of the FCC’s equipment authorization database reveals several hundred certifications for radios
capable of operating across both the Federal and non-Federal mobile bands.
123 Alfred Mann Foundation ex parte, ET Docket No. 09-36, filed Sept. 12, 2011 (AMF 2011 Rules); Alfred Mann
Foundation ex parte, ET Docket No. 09-36, filed Sept. 26, 2011.
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59. To be able to switch to another frequency band when an existing band becomes unavailable
due to high levels of interference, it will be necessary for an MMN to be aware of the potential for
interference in all four frequency bands. To that end, we adopt the requirement suggested by AMF that
the programmer/controller (P/C) of an MMN monitor all four available frequency bands. For the band in
which the MMN is operating, the P/C must check at least once a second for interference so as to be able
to switch frequency bands to avoid disabling amounts of interference.124 Because most of the potential
interferers in these bands such as land mobile, BAS, and amateur stations, typically transmit far longer
than one second, a once-a-second monitoring interval should be sufficient to detect interfering signals.125
The P/C must be capable of determining when either direction of the communication link between the P/C
and the implanted devices is becoming degraded to the extent that communication is likely to be lost for
more than 45 milliseconds. As suggested by AMF, we will require the P/C to move the MMN to another
frequency band upon making this determination. As suggested by AMF, we will require the P/C to
monitor the other frequency bands often enough such that when it must switch frequency bands it has
determined which frequency band is available based on monitoring of that band during the two second
period prior to switching. According to AMF, incorporating a requirement to monitor MMN channels
prior to executing a channel change “will not materially increase production costs.”126 This is not
surprising considering that radios now operating in these bands also have a requirement to monitor
channels prior to transmitting on them127 and that the technology and techniques to accomplish spectrum
monitoring in these bands are well established. Thus, we conclude that the benefits of these monitoring
requirements far outweigh the expected costs to comply.
60. Because the MMN devices operate with such low power, we do not believe that they will
cause interference to other stations sharing the same frequency bands. However, out of an abundance of
caution we will adopt one additional monitoring requirement to further reduce the risk of interference.
We will require the P/C to switch to another frequency band if during the monitoring of the occupied
frequency band it determines that there is a received signal with power greater than -60 dBm in any 12.5
kHz bandwidth being used by the MMN device that persists for at least fifty milliseconds.128 A received
signal of this strength is likely to be caused by a station in close proximity to the P/C. We are using a
measurement bandwidth of 12.5 kHz for this determination because this is the signal bandwidth used by
all Federal land mobile stations. Non-Federal land mobile operations are currently undergoing a
migration from using 25 kHz channels to 12.5 kHz channels, and consequently, in the near future the
majority of licensees will also be limited to signal bandwidths of 12.5 kHz.129 We are choosing this
measurement bandwidth based on land mobile stations because they are the most numerous stations that


124 AMF proposed that the P/C have a mechanism for monitoring the channel or channels that the MMN intends to
occupy. AMF Comments appendix B, at 2.
125 Most of the radar signals present in these bands are pulse radars with short duration signals. Because we are
requiring that MMN P/Cs only transmit at most three percent of the time, the MMNs should be able to operate in the
presence of these radars without switching to another frequency band. See paragraph 81, supra.
126 See Comments of Alfred Mann Foundation ex parte, ET Docket No. 09-36, filed Nov. 15, 2011 at 2-3.
127 See, e.g., 47 C.F.R. § 90.403(e).
128 AMF and the United States Department of Defense agreed to the -60 dBm threshold and fifty millisecond signal
duration. Alfred Mann Foundation ex parte, ET Docket No. 09-36, filed Nov. 17, 2011 (AMF 11/17/11 ex parte).
129 Implementation of Sections 309(j) and 337 of the Communications Act of 1934 as Amended, WT Docket No. 99-
87, Second Report and Order and Second Notice of Proposed Rulemaking, 18 FCC Rcd 3034, 3038-39 para. 12
(2003); 47 C.F.R. § 90.209(b)(5). We note that licensees may still use 25 kHz channels if they employ a technology
that achieves the narrowband equivalent of at least one channel per 12.5 kHz of channel bandwidth for voice and
transmission rates of at least 4800 bits per second per 6.25 kHz for data systems operating with bandwidths greater
than 12.5 kHz (narrowband-equivalent technology).
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will share these frequency bands with MMNs.130
This requirement should prevent the unlikely
occurrence of interference from an MMN device to another service sharing the same frequency band.
61. There may occasionally be instances when MMNs may not be able to function because of
high levels of interference in all four frequency bands. To account for these infrequent occurrences, the
rules we adopt will require that all MMN transmitters incorporate a programmable means to implement a
system shutdown process in the event of a communication failure or on command from the P/C. Because
MMNs are used to provide therapeutic benefits to patients, such as providing them with a means to move
muscles that they would not otherwise be able to move, it is important that we require the MMNs to
incorporate a means to implement a pre-defined system shutdown process.131 We believe that this
requirement offers vital benefits to patients and is integral to the success of the MMN system design.
Because MMNs are sophisticated electronic devices and the programming necessary to implement a
system shutdown process should represent only a portion of the overall design costs, we conclude that the
benefits of a system shutdown requirement far outweigh any associated costs. As suggested by AMF, we
will require that this shutdown process commence within 45 milliseconds after loss of the communication
link or receipt of the shutdown command from the P/C.132
62. Contention Protocol Requirement. In the NPRM, the Commission sought comment on a
number of questions related to contention protocols, such as whether a contention protocol should be
applied to MMN transmitting devices, what kinds of contention protocols should or should not be used,
and how a contention protocol might be developed.133 A contention protocol would be aimed at allowing
multiple MMN systems to share the specified frequency bands without causing interference to each other.
This approach differs from the interference mitigation techniques that AMF’s MMN devices employ.
These techniques are designed to allow the MMNs to function in the presence of interference from other
services sharing the same frequency bands. Commenters supported the idea of MMNs using a contention
protocol, but no one specified a particular contention protocol that we could adopt. For example, AMF
proposed rules that include a requirement that all MMN stations employ the same contention-based
protocol but did not define a specific contention-based protocol.134 The Cleveland FES Center (CFC)
encourages the use of an open-source contention protocol, but it offers no particulars regarding the
characteristics such a protocol should have, while AMF argues that CFC’s proposal is too vague and
indefinite to include in the rules.135 Sienkiewicz points out that if devices use different protocols they
may be unable to effectively share the frequency band and stresses the need for one protocol to be used by
all devices.136 He suggests it may be in the public interest to require that a protocol be developed by a
particular date.137 Strother, on the other hand, encourages the Commission to consider adopting general


130 It is important not to choose a bandwidth greater than 12.5 kHz because this would potentially aggregate the
power from multiple stations and result in meeting the -60dBm limit even when the MMN is not in close proximity
to any of the stations. We note that other stations operating in these bands such as amateur and BAS stations should
also have enough power concentrated within a 12.5 kHz bandwidth to trigger this threshold when in close proximity
to an MMN, even though they use larger bandwidth signals.
131 We will not specify a specific shutdown routine as that will necessarily depend on the function the MMN is
designed to perform (e.g. restore sensitivity vs. enable movement).
132 See paragraph 51, supra.
133 NPRM at 3455-56 paras. 37-39.
134 AMF Comments Appendix B at 5, 6. Motorola states that without details of the contention protocol it cannot
provide an opinion as to the effectiveness of the protocol used in the AMF MMNs. Motorola Comments at 9.
135 Cleveland FES Comments at 2.
136 Sienkiewicz Comments at 6-7
137 Id. at 11. According to Sienkiewicz, the typical approach to developing a protocol is to form a working group to
develop it. Id. at 7.
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performance requirements, which would allow for the implementation of multiple protocols that might
have specific advantages for different applications while ensuring spectrum sharing across device
manufacturers and applications.138
63. We appreciate that requiring MMNs to use a common contention protocol would enable
MMNs to more efficiently share the available spectrum. However, as no commenters have suggested a
specific contention protocol, we cannot adopt a requirement for use of a specific contention protocol at
this time.139 We also will not require the development of a contention protocol by a particular date as
suggested by Sienkiewicz. Given the novelty of MMN technologies, we are not able to predict when
entities other than AMF will develop MMNs for use in these bands and therefore have no grounds to
speculate on how and in what timeframe a contention protocol may be developed. We do encourage
manufacturers of MMN devices to cooperate in the development of a contention protocol so that the
MMN devices may more effectively share the limited available spectrum.140 If, in the future, parties
establish a specific contention protocol that they believe should be applied to these bands, they are
welcome to file a Petition for Rulemaking to bring such information to our attention.
64. In the NPRM, the Commission also sought comment on using the listen-before-talk (LBT)
approach of the existing MedRadio service rules to share spectrum between different MMNs. Under this
approach, a transmitting device must monitor a frequency band for the presence of other MedRadio
transmitters before beginning transmissions in that frequency band.141 If a signal with power above a
certain threshold is detected, the transmitting device is not allowed to transmit in that frequency band.
As we described above, we have adopted a similar requirement with a high power threshold (-60 dBm in
a 12.5 kHz bandwidth) to help guard against the unlikely occurrence of interference from MMNs to other
services sharing the same frequency band.142
Use of this high threshold will not be effective in
facilitating MMN-to-MMN sharing because MMNs transmit such low power over a wide bandwidth. We
will not adopt a similar requirement with a lower LBT threshold because it would interfere with the
functioning of the interference mitigation techniques employed by AMF’s MMN devices.143 The MMN
devices would not be able to determine whether a detected signal with a power above the LBT threshold
is from another MMN or is a signal from another service sharing the same frequency band. Because
MMNs should be designed to operate in the presence of a certain level of interference from other services
operating in the same frequency band, not transmitting when signals above a lower LBT threshold are
present would lead to MMNs not making use of the available spectrum effectively.
65. Permissible Communications and Operator Eligibility. In the NPRM, the Commission
sought comment on restricting implant devices for use by persons only for diagnostic and therapeutic


138 Comments of Bob Strother, ET Docket 09-36, filed Aug. 12, 2009, at 3 (Strother Comments). The performance
requirements can include maximum continuous message duration, minimum listen-before-talk monitor intervals,
maximum allowable delay between listen-before-talk monitoring intervals, etc.
139 Considering the fact that AMF has proposed a rule requiring that all MMNs use the same contention protocol, we
presume that their MMNs employ such a protocol. However, they have not revealed this protocol in the record. In
the NPRM the Commission also sought comment on adopting the general definition of contention-based protocol
that is used under Part 90 of the rules in the 3650 MHz band. NPRM at 3455-56 para. 37. Because we are not
requiring use of a contention protocol, we have no need to adopt a definition of a contention-based protocol.
140 We agree with Sienkiewicz that any common contention protocol that is developed should be available to
everyone (i.e. published and not encumbered by intellectual property). Sienkiewicz Comments at 7.
141 See 47 C.F.R. § 95.628(a); NPRM at 3456 para. 38.
142 See paragraph 60, supra.
143 Sienkiewicz questions the appropriateness of a listen-before-talk protocol because of the potentially time critical
data in a medical device network. Sienkiewicz Comments at 6.
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purposes and only to the extent that such devices have been provided to a human patient under the
direction of a duly authorized health care professional. This requirement is present in our existing
MedRadio rules144 and is consistent with how we expect MMNs to be used. No one has raised an
objection to this requirement. We will therefore apply this restriction for MMNs.
66. The Commission also sought comment on prohibiting the medical implant
programmer/controller (P/C) from relaying information to a receiver that is not included with a medical
implant device. This prohibition is included in the existing MedRadio rules. AMF states that the
restriction preventing MedRadio programmer/controllers from relaying information to a receiver not
included in a medical implant device should not apply to MMNs so that different MMNs can exchange
information to mitigate potential interference between the MMNs.145 Sienkiewicz agrees that different
programmer/controllers should be able to communicate with each other.146
67. We will allow P/Cs in different MMNs to communicate with each other for the purposes of
coordination of the use of the spectrum resource. This differs from our existing MedRadio rules, which
prohibit controller-to-controller communication. We expect that each MMN will use a spectrum band for
short periods of time as is the case for AMF’s MMNs.147 Because of this, multiple MMNs should be able
to share a frequency band without causing interference to each other. If the P/Cs for different MMNs
from the same manufacturer are able to communicate with each other, they can coordinate their networks’
respective transmissions to avoid transmitting at the same time in the same frequency bands.
68. While we will allow P/C-to-P/C communications to facilitate sharing of the scarce spectrum
resource, we will not permit P/Cs to communicate with non-implanted devices for other purposes. This
will prevent the 413-457 MHz spectrum from being used as backhaul to move data from an MMN to
devices outside the network. This is the rule currently in place for MedRadio devices under our existing
rules and is needed because the 413-457 MHz band remains reserved only for those medical applications
that cannot be achieved in other spectrum and allowing other transmissions would cause undesirable
spectrum congestion.148
69. The Commission also sought comment in the NPRM on whether implant-to-implant
communications should be allowed, whether each programmer/controller must always control the
transmitters implanted in a single patient, and whether all implants in a patient must be controlled by a
single programmer/controller. Bob Strother (Strother) and the Cleveland FES Center suggest that we
adopt rules permitting implant-to-implant communication.149 Sienkiewicz agrees, noting that there is
substantial research into how multiple independent units can cooperate without a central control
system.150 AMF disagrees because this would be a significant departure from the MedRadio rules, which
AMF argues properly serve to manage RF transmissions to and from implant devices.151 Sienkiewicz also
suggests that multiple MMNs with separate controllers should be allowed in a single patient and that a


144 47 C.F.R. § 95.1201.
145 AMF Comments at 15.
146 Sienkiewicz Comments at 3.
147 See discussion of maximum duty cycle in paragraph 81, supra. AMF 2011 Rules at 2.
148 47 C.F.R. § 95.1209(e). The transmission of data from a P/C to devices outside the body does not require the use
of the 413-457 MHz band with its favorable in-body propagation characteristics because the transmissions will
occur outside of the human body.
149 Cleveland FES Comments at 2; Strother Comments at 2.
150 Sienkiewicz Comments at 3-4.
151 AMF Reply at 15.
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single programmer/controller should be able to control implants in more than one patient.152
70. We will not permit implant-to-implant communications. In making the decision to allow
MMNs to use spectrum in the 413-457 MHz band, we have been favorably impressed by the interference
mitigation techniques that AMF has demonstrated in the independent test described in the Aerospace
Report. The system tested relied on a P/C external to the body to schedule the implant transmissions in
accordance with these mitigation techniques. We have no evidence on the record that MMNs can
successfully mitigate the effects of interference if implants are permitted to communicate with each other
outside the control of a P/C. As a result, we cannot reach the conclusion that such a network would be
able to function in these bands with the incumbent services.
71. We will allow multiple MMNs to exist within a single patient with each network having its
own separate P/C. The configuration of the networks for a particular patient should be determined by the
medical needs of the patient and the limits of existing technology. This may require the use of different
networks to accomplish different functions. On the other hand, we will not permit a P/C to control
implanted devices in multiple patients. Given the power limits of the MMN devices, we expect that the
P/C will have to be within a few meters of the patient at all times. Allowing a single P/C to control
implants in more than one patient would require the patients to remain in close proximity at all times,
which does not appear to be practical. No commenter has suggested a scenario for which such an
accommodation would be useful.
72. Emission Bandwidth. In the NPRM, we sought comment on the maximum emission
bandwidth that should be allowed for MMN devices.153 Each of the four segments of the 413-457 MHz
band allocated in this proceeding for use by MMN devices occupies six megahertz of spectrum.
Alternatively, we also sought comment on whether a smaller maximum emission bandwidth (e.g., three
megahertz) might be sufficient for MMN purposes and might further improve spectrum use and
efficiency.
73. AMF has submitted proposed rules that specify a five-megahertz maximum emission
bandwidth.154 Sienkiewicz states that there is no point to having a six-megahertz band limited to five
megahertz signals and that the rules should not be limited to the minimum requirements for AMF’s
devices.155
Strother believes that a three-megahertz bandwidth is reasonable for any application
conceivable at this time.156
74. We shall adopt a maximum emission bandwidth of six megahertz. We see no reason to limit
the emission bandwidth to three or five megahertz considering that we are allocating six megahertz bands
for use by MMNs. This will provide flexibility for future, more efficient system design. We note that the
maximum emission bandwidth of the MMN signals will also be constrained by the unwanted emission
limits that we are adopting.157
75. Channelization.
In the NPRM, the Commission suggested that one approach to
channelization would be to adopt rules that do not specify any particular channeling plan, thereby


152 Sienkiewicz Comments at 3-4.
153 NPRM at 3454 para. 35.
154 AMF Comments Appendix B at 3.
155 Sienkiewicz Comments at 5.
156 Strother Comments at 2.
157 See paragraph 82, infra.
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following the approach used with the existing MedRadio Service.158 We sought comment on whether we
should require a specific channel plan.
76. In the rules that AMF proposed, the MMN devices would transmit with a specified center
frequency and channel boundaries in each of the four proposed frequency bands.159 The Cleveland FES
Center suggests that the Commission not specify a channel plan.160
Sienkiewicz points out that
channelization can lead to more efficient use of spectrum, but only if devices are designed to cooperate in
the use of the channels.161 He states that if the four frequency bands are subdivided into channels this will
raise the issue of what to do with devices that need more bandwidth than a single channel.
77. No parties have suggested a channelization plan other than AMF’s proposal for centering the
signals in each of the four bands. Given that no parties have suggested a channelization plan, we have no
grounds for adopting one, nor do we see any reason to specify that emissions be based around a center
frequency in each of the four bands as AMF has proposed. Because MMN manufacturers will have to
design equipment to operate on specific frequencies, we recognize that there would be little or no added
equipment design cost if we were to specify a particular channel plan or center frequency. Nevertheless,
we see no benefit in doing so, as it would limit the flexibility available for future system design.
Accordingly, we will not adopt rules specifying a channelization plan for MMN devices.
78. Transmitter Power. In the NPRM, the Commission sought comment on the appropriate
transmitted power for MMNs.162 AMF suggested in its petition that each implantable microstimulator
could be limited to a maximum EIRP of 200 microwatts and each P/C transmitter could be limited to a
maximum EIRP of 1 milliwatt. In the draft rules it submitted with its petition, AMF proposed transmitter
power limits that did not distinguish between implant and P/C maximum power levels. These rules would
require that the MedRadio transmitters be limited to a maximum EIRP of the lesser of 1 milliwatt or (10
log B – 6.866) dBm, where B is the 20 dB emission bandwidth of the transmitted signal in MHz and that
the peak power spectral density shall not exceed 800 microwatts per MHz in any 1 MHz band. No
commenters specifically addressed AMF’s proposed power limits. The NPRM also sought comment on
what measurement methods would be appropriate for establishing compliance with the EIRP limits,
whether there should be an upper limit on the number of devices in an MMN, whether the EIRP of
devices should be aggregated in some manner, and if we should consider any other operational factors.
79. We shall adopt the transmitter power limits in AMF’s proposed rules with one minor change
to reflect the fact that we are allowing MMNs to use a six megahertz maximum emission bandwidth
instead of a five megahertz emission bandwidth as AMF proposed. We will limit the maximum EIRP of
any MMN transmitter to the lesser of 1 mW or (10 log B – 7.782) dBm where B is the 20 dB emission
bandwidth of the transmitted signal in MHz.
As discussed above, we believe that these devices
transmitting at these power limits will not cause interference to other services in the 413-457 MHz band.
The rules we adopt will apply the same transmitter power limits to both implanted transmitters and the
P/C transmitter. We see no reason to apply a stricter power limit to implanted transmitters considering
that the signals from these devices will be attenuated by body tissue. For this reason an implanted
transmitter is even less likely to cause interference than a P/C transmitter operating at the same power
level. We will also not place a limit on the number of devices in an MMN network or aggregate the
powers of the devices. No one has suggested a limit on the number of devices or how the power of


158 See 47 C.F.R. § 95.628 (a)(6)(ii).
159 AMF Comments Appendix B at 2.
160 Cleveland FES Comments at 2.
161 Sienkiewicz Comments at 6.
162 NPRM at 3456-57 paras. 41-42.
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multiple devices may be aggregated. We note that because the implant devices in an MMN will only
transmit under the control of the P/C, as a practical matter only one implant device in an MMN would
transmit at any one time.163 Consequently, we see no need to aggregate the powers of the multiple
devices in the MMN for purposes of establishing a transmitter power limit.
80. Duty Cycle. In the NPRM, the Commission sought comment on the appropriate duty cycle
requirements for MMNs.164 In its petition AMF stated that “each implanted microstimulator transmits
data for approximately 5 microseconds every 11 milliseconds and receives data for approximately 6
microseconds every 11 milliseconds (i.e., less than 0.05 percent transmit duty cycle). For a system with
10 to 20 implanted microstimulators, the transmit duty cycle of the MCU is approximately 3 percent.”165
AMF made a similar statement in its comments filed subsequent to the NPRM when describing the
operation of its prototype MMNs, but it did not include a duty cycle specification in the rules it
concurrently proposed.166 In a recent ex parte submission, AMF indicated that it had reached agreement
with the United States Department of Defense that a 3 percent maximum duty cycle for P/Cs would be
appropriate.167

81. We find that it is important to specify a maximum duty cycle for MMNs. Because each P/C
will occupy a frequency band for a fraction of the time, other MMNs will be able to make use of the
frequency band during the remainder of the time, thus facilitating sharing among multiple MMNs.
Specifying a maximum duty cycle will also help the MMNs share the frequency bands with pulse radars
with short duration signals that are present in the 426-432 MHz and 438-444 MHz bands.168 As discussed
above, based on the JSC Report and Aerospace Report, we have concluded that the record demonstrates
that MMNs can operate on a compatible secondary basis with primary Federal systems in these bands.169
The JSC Report assumed a P/C duty cycle of 3 percent in conducting the analysis that concluded that
MMNs would be operationally compatible and not cause interference to Federal systems.170 Because we
have no information on how the conclusions of the JSC Report would be affected if the P/C duty cycle
were allowed to rise above 3 percent, and in recognition of the concurrence of AMF and the Department
of Defense that a 3 percent maximum duty cycle is appropriate for MMNs, we adopt rules that specify a
maximum duty cycle of 3 percent for P/Cs.
82. Unwanted Emissions. The existing MedRadio rules under Part 95 set limits on unwanted
emissions from medical transmitting devices operating in the 401-406 MHz band.171 As delineated
therein, these provisions include limits on both in-band and out-of-band radiation. AMF has proposed


163 Even in cases where multiple MMNs are operating in close proximity (such as two MMNs in the same person),
these devices would still be implanted, small in number, and would not necessarily be operating simultaneously.
164 NPRM at 3456-57 paras. 41-43. Duty cycle is the proportion of time during which a device is operated. The
duty cycle can be expressed as a ratio or as a percentage.
165 AMF Petition at 17.
166 AMF Comments at 9. AMF also did not include a duty cycle specification with the rules it proposed when it
submitted its petition. In a subsequent submission, it proposed a maximum duty cycle for P/Cs of 10 percent but did
not discuss how it arrived at this number. See AMF 2011 Rules at 2.
167 AMF 11/17/11 ex parte.
168 Letter from the National Telecommunications Infrastructure Administration, WT Docket 09-36, filed Feb. 27,
2009, at 2-5.
169 See paragraph 42, supra.
170 JSC Report at 13.
171 See 47 C.F.R. § 95.635(d).
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emissions limits that are similar to the existing MedRadio rules.172 No parties commented on the
unwanted emissions limits. The rule we adopt applies these emissions limits to these frequency bands.
Under this approach, in the first 2.5 megahertz beyond any of the frequency bands authorized for MMN
operation, the EIRP level associated with any unwanted emission must be attenuated within a 1 megahertz
bandwidth by at least 20 dB relative to the maximum EIRP level within any 1 megahertz of the
fundamental emission.173 In addition, emissions more than 2.5 megahertz outside of the authorized
bandwidth must meet the frequency-dependent set of electric field strength limits of new Section
95.635(d)(1)(iv) of the rules as set forth in Appendix A.174
83. Frequency Stability. In the NPRM, we sought comment on whether each MMN transmitter
should be required to maintain a frequency stability as specified in the current MedRadio rules of +/- 100
ppm of the operating frequency over the range: (1) 25°C to 45°C in the case of MMN implant
transmitters; and (2) 0°C to 55°C in the case of MMN programmer/control transmitters. AMF suggested
extending this existing frequency stability criterion in its rulemaking petition.175 Sienkiewicz argues that
a frequency stability requirement is unnecessary if there is no channelization scheme and that devices
from different manufacturers do not need to talk to each other (i.e., if there is no common contention
protocol). Even if a frequency stability criterion is needed, he thinks that the criterion can be ten times
more relaxed than the suggested standard, but he acknowledges that the +/- 100 ppm standard is common
in off-the-shelf oscillators.176
84. The +/- 100 ppm frequency stability criterion is the standard for MedRadio devices in the
current rules and represents good engineering practice. As Sienkiewicz acknowledges, oscillators that
meet this standard are readily available. AMF, which has built functioning equipment, believes it is an
appropriate standard. We agree and see no reason to depart from the current MedRadio frequency
stability criterion. We will apply this standard to MMN devices.
85. Antenna Locations. In the NRPM, we sought comment on applying the existing MedRadio
requirement that no antenna for a control transmitter be configured for permanent outdoor use.177 No one
objected to this proposal, and we will retain this rule for MMNs. Additionally, ARRL stated that only
portable, body-worn MMN devices should be permitted and that no fixed antenna is appropriate in this
frequency range.178 The rules we adopt permit only MMNs that contain implanted devices and a
programmer/controller transmitter to operate in the MedRadio Service in these frequency bands and the
limited transmit power permitted under our rules will limit the programmer/controller to locations on or in
close proximity to the patient. Because the rules will effectively restrict MMNs to portable body-worn
devices and preclude the use of fixed antennas, we conclude that it is unnecessary for us to adopt a new


172 AMF Comments Appendix B at 4-5. We note that AMF proposed different frequency ranges for these unwanted
emission limits when it filed its petition. AMF Petition Appendix A at 5. We mentioned these earlier proposed
frequency ranges in the NPRM. NRPM at 3457 at para. 46. We are basing our adopted rules on AMF’s later
submitted proposed rules.
173 For example, for the 413-419 MHz band, emissions below 410.5 MHz and above 421.5 MHz would have to be at
least 20 dB below the transmitter output power.
174 These frequency dependent limits are the same frequency dependent field strength limits presently specified in
Section 95.635(d)(1) for the MedRadio Service.
175 AMF Petition Appendix A at 4.
176 Sienkiewicz Comments at 9-10.
177 Under the existing MedRadio rules, any MMN control transmitter used outdoors would not be allowed to be
affixed to any structure for which the height to the tip of the antenna will exceed three (3) meters (9.8 feet) above
ground. 47 C.F.R. § 95.1213.
178 ARRL Comments at 15.
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rule containing these restrictions..
86. RF Safety. In the NPRM, the Commission noted that portable devices are subject to Section
2.1093 of its rules, pursuant to which an environmental assessment must be prepared under Section
1.1307, and that these rule sections also govern existing MedRadio devices.179 The Commission further
noted that its ongoing RF safety proceeding (ET Docket No. 03-137) anticipated dealing with proposed
changes in the Commission’s rules regarding human exposure to RF electromagnetic fields in a more
comprehensive fashion. The NPRM only sought comment on whether MMN implant and
programmer/controller transmitters should be deemed portable devices subject to Sections 2.1093 and
1.1307 of the existing rules. No commenters addressed this issue. Because existing MedRadio devices
are considered portable devices and we have no reason to treat MMN devices differently, we shall deem
MMN devices to be portable devices subject to sections 2.1093 and 1.1307 of our rules.180
87. The ARRL stated that “no rules should be enacted without a comprehensive series of field
tests that assure patient safety in the presence of typical RF fields in the bands at issue in this
proceeding.”181 To the extent that these comments relate to RF safety matters, they are misplaced.182
Given the ongoing Commission proceeding on RF safety in ET Docket 03-137, the NPRM did not request
duplicative comment in this proceeding. Rather, the only question we raised in the NPRM that implicated
RF safety concerns was the categorization issue, i.e., whether MMN devices should be subject to the RF
exposure limits applicable to portable devices, as are other MedRadio devices,183 or the limits applicable
to mobile devices.184
Consequently, because matters concerning RF safety are more appropriately
addressed in ET Docket 03-137 and not here ARRL should raise any specific concerns it has regarding
RF safety directly in ET Docket 03-137.
88. Miscellaneous Provisions. In the NPRM, we sought comment on a number of provisions
regarding equipment certification, authorized locations, station identification, station inspection,
disclosure policy, labeling requirements, and marketing limitations that mirror the existing MedRadio
rules.185
89. As the Commission proposed in the NPRM, we will require each MMN transmitter
authorized to operate in the 413-457 MHz band to be certificated. 186 This requirement will not apply to
transmitters that are not marketed for use in the United States, are being used in the United States by
individuals who have traveled to the United States from abroad, and comply with the applicable technical


179 NPRM at 3458 para. 49.
180 The AMF petition proposed that references to MMNs be added to sections 1.1307 and 2.1093 of our rules
regarding environmental assessments and radiofrequency radiation exposure, respectively. AMF Petition Appendix
A at 1-2. Because MMNs are treated as part of the MedRadio Service and MedRadio is listed in these sections, we
do not need to amend these rules.
181 ARRL Comments at 10.
182 Because ARRL’s reference to “patient safety” is in a portion of its comments that address the interference
susceptibility of MMNs, it is not clear whether it is raising specific RF safety concerns. Insofar as ARRL is only
talking about the ability of MMNs to operate as designed (and therefore avoid harm to patients), we are convinced
that they will be able to do so. See footnote 90, supra.
183 See NPRM, 24 FCC Rcd at 3458 para. 49. See also 47 C.F.R. §§ 2.1093, 1.1307, 95.1221. Section 2.1093
defines “portable devices” as devices that are used within 20 cm of the body of the user.
184 See 47 C.F.R. §§ 2.1091. Section 2.1091 defines “mobile devices” as devices other than those to be operated at a
fixed location and are used more than 20 cm away from the body of the user.
185 NPRM at 3458-59 paras. 50-55; 47 C.F.R. §§ 95.1203-07, 95.1215-19.
186 47 C.F.R. § 95.603(f).
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requirements. We will also adopt the proposals in the NPRM that MedRadio devices in the 413-457 MHz
band be authorized to operate anywhere CB station operation is authorized under § 95.405 and not be
required to transmit a station identification announcement.187 In addition, we will apply the existing
MedRadio rule that requires that all non-implanted MMN transmitters be made available for inspection
upon request by an authorized FCC representative.188 Under this provision, persons operating implanted
MMN transmitters are required to cooperate reasonably with duly authorized FCC representatives in the
resolution of interference. These requirements are all the same as the existing MedRadio rules for the
401-406 MHz band. No commenters objected to any of these proposals.
90. In the NPRM, the Commission sought comment on whether to require the manufacturers of
MMN transmitters to include with each transmitting device the following disclosure statement:
This transmitter is authorized by rule under the MedRadio Service (47 C.F.R. Part 95).
This transmitter must not cause harmful interference to stations authorized to operate on a
primary basis in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands,
and must accept interference that may be caused by such stations, including interference
that may cause undesired operation. This transmitter shall be used only in accordance with
the FCC Rules governing the MedRadio Service. Analog and digital voice communications
are prohibited. Although this transmitter has been approved by the Federal
Communications Commission, there is no guarantee that it will not receive interference or
that any particular transmission from this transmitter will be free from interference.189
The Commission also sought comment on requiring that MMN programmer/control transmitters be
labeled and bear the following statement in a conspicuous location on the device:
This device may not interfere with stations authorized to operate on a primary basis in the
413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands, and must accept
any interference received, including interference that may cause undesired operation.190
The Commission did not propose an analogous labeling requirement for implant transmitters but instead
sought comment on whether to require that the implant transmitters be identified with a serial number.191
91. The ARRL argues that the certification process should include regulation of the written
information that should be provided to patients and medical providers regarding the interference
susceptibility of the devices.192 According to the ARRL, the disclosure and labeling language proposed in
the NPRM are insufficient and are an abdication of the Commission’s obligation to patients to place
MMN devices in a band where they will not receive harmful interference or malfunction in the presence
of strong RF signals. SBE complains that Part 15 type disclaimers as proposed in the NPRM are useless
once the devices are implanted.193
SBE considers the proposed notices an abdication of the
Commission’s obligation to make spectrum allocations based on a finding that the interference potential is
predictably low and that merely stating there is no guarantee a device will function correctly is


187 47 C.F.R. §§ 95.1203, 95.1205. CB radio operation is operation is permitted in any area of the world where radio
services are regulated by the Commission. 47 C.F.R. § 95.405.
188 47 C.F.R. § 95.1207. For MMNs this provision will apply only to programmer/control transmitters.
189 See NPRM at 3458 para. 53; 47 C.F.R. § 95.1215.
190 See NPRM at 3459 para. 54; 47 C.F.R. § 95.1217. The Commission’s rules require that any equipment covered
in an application for equipment authorization bear a nameplate or label that contains an FCC identifier and any other
statement or labeling imposed by the rules. 47 C.F.R. § 2.925(a).
191 See 47 C.F.R. § 95.1217(c).
192 ARRL Comments at 14.
193 SBE Comments at 7.
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unacceptable. Sienkiewicz believes that the proposed notice may not be blunt enough for the average
user and proposes text that is not “legal-sounding.”194 He suggests that the regulations require that users
be warned that interference may occur, even if it is unlikely, and that MMNs must be operated so that
they do not pose a risk to others.
92. Both ARRL and SBE base their opposition to our proposed notice and labeling requirements
at least in part on the fact that the MMN devices cannot be guaranteed to function at all times because of
possible interference from other services in these bands. We have addressed this concern above and
therefore have no need to discuss this issue further.195 We also do not believe that the proposed labeling
will be “useless” once the implanted MMN devices are placed within the body because only the P/C
transmitter will bear a label, and it will not be implanted in the body. The proposed disclosure and
labeling statements are based on the requirements for the MedRadio Services (and the MICS before that)
that have been in place since 1999.196 These notices have served us well since that time, and we see no
reason to change them now. We note that MMN devices are medical devices which will be used only
under the direction of knowledgeable medical personnel. As such, the notices are not aimed at consumers
but instead at medical professionals who are in the best position to give appropriate patient advice. We
therefore believe that the notice and labeling requirements are sufficient and will adopt them as proposed.
These disclosure and labeling requirements provide an important benefit to medical professionals by
warning of the secondary status of the MMN devices. These requirements are consistent with those that
are in place for similar medical devices that are authorized under the Commission’s rules, and so the costs
should be similar. Therefore, we see no reason why disclosure and labeling requirements should be more
burdensome in the case of MMNs.
93. No one commented on the proposal that implant transmitters be identified with a serial
number. This is the same requirement that MedRadio devices must meet under our existing rules. We
therefore adopt this requirement. Doing so will make it easier to identify particular MMN implant
devices, and this information is limited enough to be placed on tiny devices. As proposed, we will allow
the FCC ID number associated with the transmitter and the information required by Section 2.925 of the
FCC Rules to be placed in the instruction manual for the transmitter in lieu of being placed directly on the
transmitter.
94. In the NPRM the Commission also proposed to provide that MMN transmitters intended for
operation in any portions of the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands
may be marketed and sold only for those permissible uses described above.197 No one objected to this
proposal, which currently is part of the existing MedRadio rules. Given our expressed intent to limit use
of these frequency bands to MedRadio applications that cannot be achieved in other spectrum, we believe
that this requirement is necessary, and we therefore adopt it.

IV.

PROCEDURAL MATTERS

95. Further Information: For further information, contact Peter Georgiou, Office of Engineering
and Technology, at (202) 418-8130, or Nicholas Oros, Office of Engineering and Technology, at (202)
418-0636, Federal Communications Commission, 445 12th Street, SW, Washington, DC 20554; or via the
Internet at Peter.Georgiou@fcc.gov or Nicholas.Oros@fcc.gov, respectively.


194 Sienkiewicz Comments at 9.
195 See paragraphs 49-52, supra.
196 The MICS rules were adopted in 1999 and were replaced by the MedRadio rules in 2009. MICS R&O;
MedRadio R&O; 47 C.F.R. §§ 95.1215, 95.1217.
197 47 C.F.R. § 95.1219.
33

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FCC 11-176

96. Regulatory Flexibility Analysis. A Final Regulatory Flexibility Analysis has been prepared
for this Report and Order and is included in Appendix B.
97. Paperwork Reduction Act.
This document does not contain proposed information
collection(s) subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13.198 Therefore, it
does not contain any new or modified “information collection burden for small business concerns with
fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law
107-198, see 44 U.S.C. § 3506(c)(4).

V.

ORDERING CLAUSES

98. Accordingly, IT IS ORDERED that pursuant to the authority contained in Sections 4(i), 301,
302, 303(e), 303(f), 303(r), and 307(e) of the Communications Act of 1934, as amended, 47 USC Sections
154(i), 301, 302, 303(e), 303(f), 303(r), and 307(e), this Report and Order IS ADOPTED and Parts 2 and 95
of the Commission’s Rules ARE AMENDED as set forth in Appendix A effective 30 days after publication
in the Federal Register.
99. IT IS FURTHER ORDERED that the Commission's Consumer and Governmental Affairs
Bureau, Reference Information Center, SHALL SEND a copy of this Report and Order, including the
Final Regulatory Flexibility Analysis in Appendix B, to the Chief Counsel for Advocacy of the Small
Business Administration.
FEDERAL COMMUNICATIONS COMMISSION
Marlene H. Dortch
Secretary


198 The proposed labeling and disclosure requirements do not qualify as information collections under the PRA. 5
C.F.R. § 1320.3(c)(2).
34

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FCC 11-176

APPENDIX A

Final Rules

For the reasons discussed above, the Federal Communications Commission amends title 47 of the
Code of Federal Regulations, Parts 2 and 95, as follows:

PART 2 -- FREQUENCY ALLOCATIONS AND RADIO TREATY MATTERS; GENERAL RULES

AND REGULATIONS

1.
The authority citation for part 2 continues to read as follows:

Authority

: 47 U.S.C. 154, 302a, 303, and 336, unless otherwise noted.
2.
Section 2.106, the Table of Frequency Allocations, is amended as follows:
a. Pages 26-28 are revised.
b. In the list of United States (US) Footnotes, footnote US64 is added and footnote US345 is removed.
§ 2.106 Table of Frequency Allocations.
The revisions and additions read as follows:
* * * * *
35

399.9-400.05
399.9-400.05
MOBILE-SATELLITE (Earth-to-space) 5.209 5.224A
MOBILE-SATELLITE (Earth-to-space) US319 US320
Satellite Communications (25)
RADIONAVIGATION-SATELLITE 5.222 5.224B 5.260
RADIONAVIGATION-SATELLITE 5.260
5.220
400.05-400.15
400.05-400.15
STANDARD FREQUENCY AND TIME SIGNAL-SATELLITE (400.1 MHz)
STANDARD FREQUENCY AND TIME SIGNAL-SATELLITE (400.1 MHz)
5.261 5.262
5.261
400.15-401
400.15-401
400.15-401
METEOROLOGICAL AIDS
METEOROLOGICAL AIDS
METEOROLOGICAL AIDS
Satellite Communications (25)
METEOROLOGICAL-SATELLITE (space-to-Earth)
(radiosonde) US70
(radiosonde) US70
MOBILE-SATELLITE (space-to-Earth) 5.208A 5.208B 5.209
METEOROLOGICAL-SATELLITE
MOBILE-SATELLITE (space-to-
SPACE RESEARCH (space-to-Earth) 5.263
(space-to-Earth)
Earth) US320 US324
Space operation (space-to-Earth)
MOBILE-SATELLITE (space-to-
SPACE RESEARCH
Earth) US319 US320 US324
(space-to-Earth) 5.263
SPACE RESEARCH
Space operation (space-to-Earth)
(space-to-Earth) 5.263
Space operation (space-to-Earth)
5.262 5.264
5.264
5.264 US319
401-402
401-402
401-402
METEOROLOGICAL AIDS
METEOROLOGICAL AIDS
METEOROLOGICAL AIDS
MedRadio (95I)
SPACE OPERATION (space-to-Earth)
(radiosonde) US70
(radiosonde) US70
EARTH EXPLORATION-SATELLITE (Earth-to-space)
SPACE OPERATION
SPACE OPERATION
METEOROLOGICAL-SATELLITE (Earth-to-space)
(space-to-Earth)
(space-to-Earth)
Fixed
EARTH EXPLORATION-
Earth exploration-satellite
Mobile except aeronautical mobile
SATELLITE (Earth-to-space)
(Earth-to-space)
METEOROLOGICAL-SATELLITE
Meteorological-satellite
(Earth-to-space)
(Earth-to-space)
US64 US384
US64 US384
402-403
402-403
402-403
METEOROLOGICAL AIDS
METEOROLOGICAL AIDS
METEOROLOGICAL AIDS
EARTH EXPLORATION-SATELLITE (Earth-to-space)
(radiosonde) US70
(radiosonde) US70
METEOROLOGICAL-SATELLITE (Earth-to-space)
EARTH EXPLORATION-
Earth exploration-satellite
Fixed
SATELLITE (Earth-to-space)
(Earth-to-space)
Mobile except aeronautical mobile
METEOROLOGICAL-SATELLITE
Meteorological-satellite
(Earth-to-space)
(Earth-to-space)
US64 US384
US64 US384
403-406
403-406
403-406
METEOROLOGICAL AIDS
METEOROLOGICAL AIDS
METEOROLOGICAL AIDS
Fixed
(radiosonde) US70
(radiosonde) US70
Mobile except aeronautical mobile
US64 G6
US64
406-406.1
406-406.1
Maritime (EPIRBs) (80V)
MOBILE-SATELLITE (Earth-to-space)
MOBILE-SATELLITE (Earth-to-space)
Aviation (ELTs) (87F)
5.266 5.267
5.266 5.267
Personal Radio (95)
406.1-410
406.1-410
406.1-410
FIXED
FIXED
RADIO ASTRONOMY US74
Private Land Mobile (90)
MOBILE except aeronautical mobile
MOBILE
RADIO ASTRONOMY
RADIO ASTRONOMY US74
5.149
US13 US117 G5 G6
US13 US117
Page 26
36

Table of Frequency Allocations 410-698 MHz (UHF)
Page 27
International Table
United States Table
FCC Rule Part(s)
Region 1 Table
Region 2 Table
Region 3 Table
Federal Table
Non-Federal Table
410-420
410-420
410-420
FIXED
FIXED
Private Land Mobile (90)
MOBILE except aeronautical mobile
MOBILE
MedRadio (95I)
SPACE RESEARCH (space-to-space) 5.268
SPACE RESEARCH
(space-to-space) 5.268
US13 US64 G5
US13 US64
420-430
420-450
420-450
FIXED
RADIOLOCATION G2 G129
Amateur US270
Private Land Mobile (90)
MOBILE except aeronautical mobile
MedRadio (95I)
Radiolocation
Amateur Radio (97)
5.269 5.270 5.271
430-432
430-432
AMATEUR
RADIOLOCATION
RADIOLOCATION
Amateur
5.271 5.272 5.273 5.274 5.275
5.276 5.277
5.271 5.276 5.277 5.278 5.279
432-438
432-438
AMATEUR
RADIOLOCATION
RADIOLOCATION
Amateur
Earth exploration-satellite (active)
Earth exploration-satellite (active) 5.279A
5.279A
5.138 5.271 5.272 5.276 5.277
5.280 5.281 5.282
5.271 5.276 5.277 5.278 5.279 5.281 5.282
438-440
438-440
AMATEUR
RADIOLOCATION
RADIOLOCATION
Amateur
5.271 5.273 5.274 5.275 5.276
5.277 5.283
5.271 5.276 5.277 5.278 5.279
440-450
FIXED
MOBILE except aeronautical mobile
Radiolocation
5.286 US64 US87 US230
5.282 5.286 US64 US87 US230
5.269 5.270 5.271 5.284 5.285 5.286
US269 US270 US397 G8
US269 US397
450-455
450-454
450-454
Remote Pickup (74D)
FIXED
LAND MOBILE
Low Power Auxiliary (74H)
MOBILE 5.286AA
Private Land Mobile (90)
5.286 US64 US87
5.286 US64 US87 NG112 NG124
MedRadio (95I)
454-456
454-455
FIXED
Public Mobile (22)
LAND MOBILE
Maritime (80)
5.209 5.271 5.286 5.286A 5.286B 5.286C 5.286D 5.286E
US64 NG12 NG112 NG148
MedRadio (95I)
455-456
455-456
455-456
455-456
FIXED
FIXED
FIXED
LAND MOBILE
Remote Pickup (74D)
MOBILE 5.286AA
MOBILE 5.286AA
MOBILE 5.286AA
Low Power Auxiliary (74H)
MOBILE-SATELLITE (Earth-to-
MedRadio (95I)
5.209 5.271 5.286A 5.286B
space) 5.286A 5.286B 5.286C
5.209 5.271 5.286A 5.286B
5.286C 5.286E
5.209
5.286C 5.286E
US64
US64
37

456-459
456-459
456-460
FIXED
FIXED
Public Mobile (22)
MOBILE 5.286AA
LAND MOBILE
Maritime (80)
5.271 5.287 5.288
5.287 5.288 US64
Private Land Mobile (90)
459-460
459-460
459-460
459-460
MedRadio (95I)
FIXED
FIXED
FIXED
MOBILE 5.286AA
MOBILE 5.286AA
MOBILE 5.286AA
MOBILE-SATELLITE (Earth-to-
space) 5.286A 5.286B 5.286C
5.209 5.271 5.286A 5.286B
5.209 5.271 5.286A 5.286B
5.287 5.288 US64 NG12 NG112
5.286C 5.286E
5.209
5.286C 5.286E
NG124 NG148
460-470
460-470
460-462.5375
FIXED
Meteorological-satellite
FIXED
Private Land Mobile (90)
MOBILE 5.286AA
(space-to-Earth)
LAND MOBILE
Meteorological-satellite (space-to-Earth)
5.289 US201 US209 NG124
462.5375-462.7375
LAND MOBILE
Personal Radio (95)
5.289 US201
462.7375-467.5375
FIXED
Private Land Mobile (90)
LAND MOBILE
5.287 5.289 US73 US201 US209
NG124
467.5375-467.7375
LAND MOBILE
Personal Radio (95)
5.287 5.289 US201
467.7375-470
FIXED
Maritime (80)
LAND MOBILE
5.287 5.288 5.289 US73
Private Land Mobile (90)
5.287 5.288 5.289 5.290
US201 US209
5.288 5.289 US73 US201 NG124
470-790
470-512
470-585
470-608
470-512
Public Mobile (22)
BROADCASTING
BROADCASTING
FIXED
FIXED
Broadcast Radio (TV)(73)
Fixed
MOBILE
LAND MOBILE
LPTV, TV Translator/Booster (74G)
Mobile
BROADCASTING
BROADCASTING
Low Power Auxiliary (74H)
5.292 5.293
NG5 NG14 NG66 NG115 NG149
Private Land Mobile (90)
512-608
5.291 5.298
512-608
Broadcast Radio (TV)(73)
BROADCASTING
585-610
BROADCASTING
LPTV, TV Translator/Booster (74G)
FIXED
5.297
NG5 NG14 NG115 NG149
Low Power Auxiliary (74H)
MOBILE
608-614
608-614
BROADCASTING
RADIO ASTRONOMY
LAND MOBILE (medical telemetry and medical telecommand)
Personal Radio (95)
RADIONAVIGATION
Mobile-satellite except aeronautical
RADIO ASTRONOMY US74
mobile-satellite (Earth-to-space)
5.149 5.305 5.306 5.307
610-890
US246
614-698
FIXED
614-698
614-698
BROADCASTING
MOBILE 5.313A 5.317A
BROADCASTING
Broadcast Radio (TV)(73)
Fixed
BROADCASTING
LPTV, TV Translator/Booster (74G)
Mobile
Low Power Auxiliary (74H)
5.149 5.291A 5.294 5.296
5.300 5.302 5.304 5.306
5.293 5.309 5.311A
NG5 NG14 NG115 NG149
5.311A 5.312
5.149 5.305 5.306 5.307
5.311A 5.320
Page 28
38

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FCC 11-176

UNITED STATES (US) FOOTNOTES
* * * * *
US64 (a) In the band 401-406 MHz, the mobile, except aeronautical mobile, service is allocated on a
secondary basis and is limited to, with the exception of military tactical mobile stations, Medical Device
Radiocommunication Service (MedRadio) operations. MedRadio stations are authorized by rule on the
condition that harmful interference is not caused to stations in the meteorological aids, meteorological-
satellite, and Earth exploration-satellite services, and that MedRadio stations accept interference from
stations in the meteorological aids, meteorological-satellite, and Earth exploration-satellite services.
(b) The bands 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz are also allocated on a
secondary basis to the mobile, except aeronautical mobile, service. The use of this allocation is limited to
MedRadio operations. MedRadio stations are authorized by rule and operate in accordance with 47 CFR
part 95.
* * * * *

PART 95 – PERSONAL RADIO SERVICES

SUBPART E – TECHICAL REGULATIONS

3. The authority citation for Part 95 continues to read as follows:

Authority:

Secs. 4, 303, 48 Stat, 1068, 1032, as amended; 47 U.S.C. 154, 303.
4. Section 95.627 is redesignated as Section 95.626, and Section 95.628 is redesignated as Section
95.627.
§ 95.626 FRS unit channel frequencies.
* * * * *
5. Newly redesignated Section 95.627 is amended by revising the heading and introductory text to read
as follows:
§ 95.627 MedRadio transmitters in the 401-406 MHz band.
The following provisions apply only to MedRadio transmitters operating in the 401-406 MHz band.
* * * * *
6. New Section 95.628 is added to read as follows:
§ 95.628 MedRadio transmitters in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457
MHz bands.

The following provisions apply only to MedRadio transmitters operating in the 413-419 MHz, 426-432
MHz, 438-444 MHz, and 451-457 MHz bands as part of a Medical Micropower Network (MMN).
(a) Operating frequency. Only MedRadio stations that are part of an MMN may operate in the 413-419
MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz frequency bands. Each MedRadio station that is
part of an MMN must be capable of operating in each of the following frequency bands: 413-419 MHz,
426-432 MHz, 438-444 MHz, and 451-457 MHz. All MedRadio stations that are part of a single MMN
39

Federal Communications Commission

FCC 11-176

must operate in the same frequency band. A MedRadio station authorized under this part must have out-
of-band emissions that are attenuated in accordance with §95.635.
(b) Frequency monitoring. MedRadio programmer/control transmitters must incorporate a mechanism for
monitoring the authorized bandwidth of the frequency band that the MedRadio transmitters intend to
occupy. The monitoring system antenna shall be the antenna used by the programmer/control transmitter
for a communications session.
(1) The MedRadio programmer/control transmitter shall be capable of monitoring any occupied
frequency band at least once every second and monitoring alternate frequency bands within two seconds
prior to executing a change to an alternate frequency band.
(2) The MedRadio programmer/control transmitter shall move to another frequency band within
one second of detecting a persistent (i.e., lasting more than 50 milliseconds in duration) signal level
greater than -60 dBm as received by a 0 dBi gain antenna in any 12.5 kHz bandwidth within the
authorized bandwidth.
(3) The MedRadio programmer/control transmitter shall be capable of monitoring the authorized
bandwidth of the occupied frequency band to determine whether either direction of the communications
link is becoming degraded to the extent that communications is likely to be lost for more than 45
milliseconds. Upon making such a determination the MedRadio programmer/control transmitter shall
move to another frequency band.
(c) MedRadio transmitters shall incorporate a programmable means to implement a system shutdown
process in the event of communication failure, on command from the MedRadio programmer/control
transmitter, or when no frequency band is available. The shutdown process shall commence within 45
milliseconds after loss of the communication link or receipt of the shutdown command from the
MedRadio programmer/control transmitter.
(d) MedRadio programmer/control transmitters shall have the ability to operate in the presence of other
primary and secondary users in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz
bands.
(e) Authorized bandwidth. The 20 dB authorized bandwidth of the emission from a MedRadio station
operating in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands shall not exceed 6
MHz.
(f) Frequency stability. Each transmitter in the MedRadio service must maintain a frequency stability of
±100 ppm of the operating frequency over the range:
(1) 25 °C to 45 °C in the case of medical implant transmitters; and
(2) 0 °C to 55 °C in the case of MedRadio programmer/control transmitters
(g) Shared access. The provisions of this section shall not be used to extend the range of spectrum
occupied over space or time for the purpose of denying fair access to spectrum for other MedRadio
systems.
(h) Measurement procedures. (1) MedRadio transmitters shall be tested for frequency stability, radiated
emissions and EIRP limit compliance in accordance with paragraphs (h)(2) and (h)(3) of this section.
(2) Frequency stability testing shall be performed over the temperature range set forth in (f) of this
40

Federal Communications Commission

FCC 11-176

section.
(3) Radiated emissions and EIRP limit measurements may be determined by measuring the radiated field
from the equipment under test at 3 meters and calculating the EIRP. The equivalent radiated field strength
at 3 meters for 1 milliwatt, 25 microwatts, 250 nanowatts, and 100 nanowatts EIRP is 115.1, 18.2, 1.8, or
1.2 mV/meter, respectively, when measured on an open area test site; or 57.55, 9.1, 0.9, or 0.6 mV/meter,
respectively, when measured on a test site equivalent to free space such as a fully anechoic test chamber.
Compliance with the maximum transmitter power requirements set forth in §95.639(f) shall be based on
measurements using a peak detector function and measured over an interval of time when transmission is
continuous and at its maximum power level. In lieu of using a peak detector function, measurement
procedures that have been found to be acceptable to the Commission in accordance with §2.947 of this
chapter may be used to demonstrate compliance.
(A) For a transmitter intended to be implanted in a human body, radiated emissions and EIRP
measurements for transmissions by stations authorized under this section may be made in accordance with
a Commission-approved human body simulator and test technique. A formula for a suitable tissue
substitute material is defined in OET Bulletin 65 Supplement C (01–01).
7. Section 95.633 is amended by revising paragraph (e) to read as follows:
§ 95.633 Emission bandwidth.
* * * * *
(e) For transmitters in the MedRadio Service:
(1) For stations operating in 402–405 MHz, the maximum authorized emission bandwidth is 300 kHz. For
stations operating in 401–401.85 MHz or 405–406 MHz, the maximum authorized emission bandwidth is
100 kHz. For stations operating in 401.85–402 MHz, the maximum authorized emission bandwidth is
150 kHz. For stations operating in 413- 419 MHz, 426-432 MHz, 438-444 MHz, or 451-457 MHz, the
maximum authorized emission bandwidth is 6 megahertz.
(2) Lesser emission bandwidths may be employed, provided that the unwanted emissions are attenuated
as provided in §95.635. See §§95.627(g), §95.628(h), and 95.639(f) regarding maximum transmitter
power and measurement procedures.
(3) Emission bandwidth will be determined by measuring the width of the signal between points, one
below the carrier center frequency and one above the carrier center frequency, that are 20 dB down
relative to the maximum level of the modulated carrier. Compliance with the emission bandwidth limit is
based on the use of measurement instrumentation employing a peak detector function with an instrument
resolution bandwidth approximately equal to 1.0 percent of the emission bandwidth of the device under
measurement.
* * * * *
8. Section 95.635 is amended by revising paragraph (d) to read as follows:
95.635 Unwanted radiation.
* * * * *
(d) For transmitters designed to operate in the MedRadio service, emissions shall be attenuated in
accordance with the following:
41

Federal Communications Commission

FCC 11-176

(1) Emissions from a MedRadio transmitter shall be attenuated to a level no greater than the field strength
limits shown in the following table when they:
(i) Are more than 250 kHz outside of the 402–405 MHz band (for devices designed to operate in the 402-
405 MHz band);
(ii) Are more than 100 kHz outside of either the 401–402 MHz or 405–406 MHz bands (for devices
designed to operate in the 401–402 MHz or 405–406 MHz bands);
(iii) Are in the 406.000-406.100 MHz band (for devices designed to operate in the 401–402 MHz or 405–
406 MHz bands); or
(iv) Are more than 2.5 MHz outside of the 413-419 MHz, 426-432 MHz, 438-444 MHz, or 451-457 MHz
bands (for devices designed to operate in the 413-457 MHz band).

Measurement

Frequency

Field strength

distance
(MHz)
(µV/m)
(m)
30–88
100
3
88–216
150
3
216–960
200
3
960 and above
500
3

Note

—At band edges, the tighter limit applies.
(2) The emission limits shown in the table of paragraph (d)(1) are based on measurements employing a
CISPR quasi-peak detector except that above 1 GHz, the limit is based on measurements employing an
average detector. Measurements above 1 GHz shall be performed using a minimum resolution bandwidth
of 1 MHz. See also §95.605.
(3) The emissions from a MedRadio transmitter must be measured to at least the tenth harmonic of the
highest fundamental frequency designed to be emitted by the transmitter.
(4) For devices designed to operate in the 402-405 MHz band: Emissions within the band more than 150
kHz away from the center frequency of the spectrum the transmission is intended to occupy and emissions
250 kHz or less below 402 MHz or above 405 MHz band will be attenuated below the maximum
permitted output power by at least 20 dB.
(5) For devices designed to operate in the 401–402 MHz or 405–406 MHz bands: Emissions between
401–401.85 MHz or 405–406 MHz within the MedRadio bands that are more than 50 kHz away from the
center frequency of the spectrum the transmission is intended to occupy (or more than 75 kHz away from
the center frequency of MedRadio transmitters operating between 401.85–402 MHz) and emissions 100
kHz or less below 401 MHz or above 406 MHz shall be attenuated below the maximum permitted output
power by at least 20 dB.
(6) For devices designed to operate in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457
MHz bands: In the first 2.5 megahertz beyond any of the frequency bands authorized for MMN
operation, the EIRP level associated with any unwanted emission must be attenuated within a 1 megahertz
bandwidth by at least 20 dB relative to the maximum EIRP level within any 1 megahertz of the
fundamental emission.
42

Federal Communications Commission

FCC 11-176

(7) Compliance with the limits described in subparagraphs (4) through (6) are based on the use of
measurement instrumentation employing a peak detector function with an instrument resolution
bandwidth approximately equal to 1.0 percent of the emission bandwidth of the device under
measurement.
* * * * *
9. Section 95.639 is amended by revising paragraph (f) to read as follows:
§95.639 Maximum transmitter power.
* * * * *
(f) In the MedRadio Service:
(1) For transmitters operating in the 401-406 MHz band that are not excepted under § 95.627(b) from the
frequency monitoring requirements of § 95.627(a), the maximum radiated power in any 300 kHz
bandwidth by MedRadio transmitters operating at 402-405 MHz, or in any 100 kHz bandwidth by
MedRadio transmitters operating at 401-402 MHz or 405-406 MHz shall not exceed 25 microwatts EIRP.
For transmitters that are excepted under § 95.627(b) from the frequency monitoring requirements of §
95.627(a), the power radiated by any station operating in 402-405 MHz shall not exceed 100 nanowatts
EIRP confined to a maximum total emission bandwidth of 300 kHz centered at 403.65 MHz, the power
radiated by any station operating in 401-401.85 MHz or 405-406 MHz shall not exceed 250 nanowatts
EIRP in any 100 kHz bandwidth and the power radiated by any station operating in 401.85-402 MHz
shall not exceed 25 microwatts in the 150 kHz bandwidth. See §§ 95.633(e).
(2) For transmitters operating in 413-419 MHz, 426-432 MHz, 438-444 MHz, or 451-457 MHz bands, the
peak EIRP over the frequency bands of operation shall not exceed the lesser of 1 mW or 10 log B – 7.782
dBm, where B is the 20 dB emission bandwidth in MHz; and the peak power spectral density shall not
exceed 800 microwatts per megahertz in any 1 megahertz band.
(3) The antenna associated with any MedRadio transmitter must be supplied with the transmitter and shall
be considered part of the transmitter subject to equipment authorization. Compliance with these EIRP
limits may be determined as set forth in § 95.627(g) or § 95.628(h), as applicable.
* * * * *
10. Appendix 1 is amended by adding the new definition “ Medical Micropower Network” to the
definitions list in alphabetical order:

Appendix 1 to Subpart E of Part 95—Glossary of Terms

Medical Micropower Network (MMN). An ultra-low power wideband network consisting of a MedRadio
programmer/control transmitter and medical implant transmitters, all of which transmit or receive non-
voice data or related device control commands for the purpose of facilitating functional electric
stimulation, a technique using electric currents to activate and monitor nerves and muscles.

Subpart I – Medical Device Radiocommunications Service (MedRadio)

11. Section 95.1209 is amended by revising paragraphs (b), (d), and (e) and by adding new paragraphs (f)
and (g) to read as follows:
43

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FCC 11-176

§95.1209 Permissible communications.
* * * * *
(b) Except as provided in §95.627(b) no MedRadio implant or body-worn transmitter shall transmit
except in response to a transmission from a MedRadio programmer/control transmitter or in response to a
non-radio frequency actuation signal generated by a device external to the body with respect to which the
MedRadio implant or body-worn transmitter is used.
* * * * *
(d) For the purpose of facilitating MedRadio system operation during a MedRadio communications
session, as defined in § 95.627, MedRadio transmitters in the 401-406 MHz band may transmit in
accordance with the provisions of § 95.627(a) for no more than 5 seconds without the communications of
data; MedRadio transmitters may transmit in accordance with the provisions of § 95.627(b)(2) and (b)(3)
for no more than 3.6 seconds in total within a one hour time period; and MedRadio transmitters may
transmit in accordance with the provisions of § 95.627(b)(4) for no more than 360 milliseconds in total
within a one hour time period.
(e) MedRadio programmer/control transmitters may not be used to relay information in the 401-406 MHz
band to a receiver that is not included with a medical implant or medical body-worn device. Wireless
retransmission of information intended to be transmitted by a MedRadio programmer/control transmitter
or information received from a medical implant or medical body-worn transmitter shall be performed
using other radio services that operate in spectrum outside of the 401-406 MHz band.
(f) MedRadio programmer/control transmitters and medical implant transmitters may not be used to relay
information in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands to a receiver
that is not part of the same Medical Micropower Network. Wireless retransmission of information to a
receiver that is not part of the same Medical Micropower Network must be performed using other radio
services that operate in spectrum outside of the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457
MHz bands. Not withstanding the above restrictions, a MedRadio programmer/control transmitter of an
MMN may communicate with the MedRadio programmer/control transmitter of another MMN to
coordinate transmissions so as to avoid interference between the two MMNs.
(g) MedRadio programmer/control transmitters operating in the 413-419 MHz, 426-432 MHz, 438-444
MHz, and 451-457 MHz bands shall not transmit with a duty cycle greater than 3 percent.
12. Section 95.1211 is amended by revising paragraphs (b) and (c) as to read as follows:
§ 95.1211 Channel use policy.
* * * * *
(b) To reduce interference and make the most effective use of the authorized facilities, MedRadio
transmitters must share the spectrum in accordance with §§ 95.627 or 95.628.
(c) MedRadio operation is subject to the condition that no harmful interference is caused to stations
operating in the 400.150-406.000 MHz band in the Meteorological Aids, Meteorological Satellite, or
Earth Exploration Satellite Services, or to other authorized stations operating in the 413-419 MHz, 426-
432 MHz, 438-444 MHz, and 451-457 MHz bands. MedRadio stations must accept any interference from
stations operating in the 400.150-406.000 MHz band in the Meteorological Aids, Meteorological
Satellite, or Earth Exploration Satellite Services, and from other authorized stations operating in the 413-
419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands.
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13. Section 95.1215 is amended to read as follows:
§ 95.1215 Disclosure policies.
(a) Manufacturers of MedRadio transmitters operating in the 401-406 MHz band must include with each
transmitting device the following statement:
“This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part
95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150-
406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers used to communicate
weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept
interference that may be caused by such stations, including interference that may cause undesired
operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical
Device Radiocommunication Service. Analog and digital voice communications are prohibited. Although
this transmitter has been approved by the Federal Communications Commission, there is no guarantee
that it will not receive interference or that any particular transmission from this transmitter will be free
from interference.”
(b) Manufacturers of MedRadio transmitters operating in the 413-419 MHz, 426-432 MHz, 438-444
MHz, and 451-457 MHz bands must include with each transmitting device the following statement:
“This transmitter is authorized by rule under the MedRadio Service (47 C.F.R. Part 95). This
transmitter must not cause harmful interference to stations authorized to operate on a primary basis in the
413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands, and must accept interference that
may be caused by such stations, including interference that may cause undesired operation. This
transmitter shall be used only in accordance with the FCC Rules governing the MedRadio Service.
Analog and digital voice communications are prohibited. Although this transmitter has been approved by
the Federal Communications Commission, there is no guarantee that it will not receive interference or that
any particular transmission from this transmitter will be free from interference.”
14. Section 95.1217 is amended by revising paragraph (a) to read as follows:
§ 95.1217 Labeling requirements.
(a) (1) MedRadio programmer/control transmitters operating in the 401-406 MHz band shall be labeled
as provided in part 2 of this chapter and shall bear the following statement in a conspicuous location on
the device:
‘‘This device may not interfere with stations operating in the 400.150–406.000 MHz band in the
Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept
any interference received, including interference that may cause undesired operation.’’
The statement may be placed in the instruction manual for the transmitter where it is not feasible to
place the statement on the device
(2) MedRadio programmer/control transmitters operating in the 413-419 MHz, 426-432 MHz, 438-444
MHz, and 451-457 MHz bands shall be labeled as provided in part 2 of this chapter and shall bear the
following statement in a conspicuous location on the device:
“This device may not interfere with stations authorized to operate on a primary basis in the 413-419
MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands, and must accept any interference received,
including interference that may cause undesired operation.”
The statement may be placed in the instruction manual for the transmitter where it is not feasible to
place the statement on the device.
* * * * *
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APPENDIX B

Final Regulatory Flexibility Analysis

1.
As required by the Regulatory Flexibility Act of 1980, as amended (RFA),1 an Initial
Regulatory Flexibility Analysis (IRFA) was incorporated in the Notice of Proposed Rulemaking
(NPRM).2 The Commission sought written public comment on the proposals in the NPRM, including
comment on the IRFA. No comments were received addressing the IRFA. This present Final Regulatory
Flexibility Analysis (FRFA) conforms to the RFA.3

A. Need for, and Objectives of, the Report and Order

2. The Report and Order (R&O) expands the Medical Device Radiocommunication (MedRadio)
Service under Part 95 of the Commission’s rules to enable the operation of medical micro-power
networks (MMNs) consisting of implantable medical devices and associated external
programmer/controllers (P/C). These MMNs will employ functional electric stimulation (or FES)
techniques to serve as an artificial nervous system to restore sensation, mobility, and function to
paralyzed limbs and organs. The R&O establishes a secondary allocation in the 413-419 MHz, 426-432
MHz, 438-444 MHz, and 451-457 MHz bands for MedRadio with use limited to MMNs.
3. The R&O adopts technical and service rules to govern the operation of MMNs in these four
frequency bands. Because MMNs will operate on a secondary basis, they must accept interference from
and not cause interference to primary services operating in these frequency bands. Consequently, these
rules must prevent MMNs from causing interference to the other services operating in these bands. Since
MMNs will be used for medical purposes, the rules must also provide assurance that they can reliably
function in these frequency bands in the presence of signals from primary services operating these bands.
For the most part the adopted rules mirror the existing rules that apply to MedRadio in the 401-406 MHz
band in Part 95 of the Commission’s rules with modifications to account for the MMN’s wider
bandwidth, higher transmission power, and need to operate in the presence of other primary services.
4. The proposed action is authorized under Sections 4(i), 301, 302, 303(e), 303(f), 303(r), and
307(e) of the Communications Act of 1934, as amended, 47 USC Sections 154(i), 301, 302, 303(e), 303(f),
303(r), and 307(e).

B. Summary of Significant Issues Raised by Public Comments in Response to the IRFA

5. There were no comments filed that specifically addressed the rules and policies proposed in
the IRFA.

C. Description and Estimate of the Number of Small Entities To Which the Rules Will

Apply

6. The RFA directs agencies to provide a description of, and, where feasible, an estimate of the
number of small entities that may be affected by the rules and policies adopted herein.4 The RFA


1 See 5 U.S.C. § 603. The RFA, see 5 U.S.C. § 601 – 612, has been amended by the Small Business Regulatory
Enforcement Fairness Act of 1996 (SBREFA), Pub. L. No. 104-121, Title II, 110 Stat. 857 (1996).
2 In the Matter of Amendment of Parts 2: and 95 of the Commission's Rules to Provide Additional Spectrum for the
Medical Device Radiocommunication Service in the 413-457 MHz band, ET Docket No. 09-36, RM-11404, Notice
of Proposed Rulemaking
, 24 FCC Rcd 3445, 3463 (2009)
3 See 5 U.S.C. § 604.
4 5 U.S.C. § 603(b)(3).
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generally defines the term “small entity” as having the same meaning as the terms “small business,”
“small organization,” and “small governmental jurisdiction.”5 In addition, the term “small business” has
the same meaning as the term “small business concern” under the Small Business Act.6 A “small
business concern” is one which: (1) is independently owned and operated; (2) is not dominant in its field
of operation; and (3) satisfies any additional criteria established by the SBA.7 Nationwide, there are a
total of approximately 27.5 million small businesses, according to the SBA.
7.

Personal Radio Services

. The Medical Device Radio Communications Services are being
placed within Part 95 of our rules (“Personal Radio Services”). The Commission has not developed a
small business size standard specifically applicable to these services. Therefore, for purposes of this
analysis, the Commission uses the SBA small business size standard for the category Wireless
Telecommunications Carriers (except Satellite), which is 1,500 or fewer employees.8 Census data for
2007 show that there were 1,383 firms that operated that year.9 Of those 1,368 had fewer than 100
employees. Personal radio services provide short-range, low power radio for personal communications,
radio signaling, and business communications not provided for in other services. The Personal Radio
Services include spectrum licensed under Part 95 of our rules and cover a broad range of uses.10 Many of
the licensees in these services are individuals and thus are not small entities. In addition, due to the fact
that licensing of operation under Part 95 is accomplished by rule (rather than by issuance of individual
license), and due to the shared nature of the spectrum utilized by some of these services, the Commission
lacks direct information other than the census data above upon which to base an estimation of the number
of small entities under an SBA definition that might be directly affected by the proposed rules adopted
herein.
8.

Wireless Communications Equipment Manufacturers.

The Census Bureau does not have
a category specific to medical device radiocommunication manufacturing. The appropriate category is
that for wireless communications equipment manufacturers. The Census Bureau defines this category as
follows: “This industry comprises establishments primarily engaged in manufacturing radio and television
broadcast and wireless communications equipment. Examples of products made by these establishments
are: transmitting and receiving antennas, cable television equipment, GPS equipment, pagers, cellular
phones, mobile communications equipment, and radio and television studio and broadcasting equipment.”
The SBA has developed a small business size standard for Radio and Television Broadcasting and
Wireless Communications Equipment Manufacturing, which is: all such firms having 750 or fewer
employees.11 According to Census bureau data for 2007, there were a total of 919 firms in this category
that operated for the entire year. Of this total, 771 had fewer than 100 employees and 148 had more than


5 5 U.S.C. § 601(6).
6 5 U.S.C. § 601(3) (incorporating by reference the definition of “small-business concern” in the Small Business
Act, 15 U.S.C. § 632). Pursuant to 5 U.S.C. § 601(3), the statutory definition of a small business applies “unless an
agency, after consultation with the Office of Advocacy of the Small Business Administration and after opportunity
for public comment, establishes one or more definitions of such term which are appropriate to the activities of the
agency and publishes such definition(s) in the Federal Register.”
7 15 U.S.C. § 632 (1996).
8 See 13 C.F.R. § 121.201, NAICS code 517210.
9 U.S. Census Bureau, 2007 Economic Census, Sector 51, 2007 NAICS code 517210 (rel. Oct. 20, 2009),
http://factfinder.census.gov/servlet/IBQTable?_bm=y&-geo_id=&-fds_name=EC0700A1&-_skip=700&;-
ds_name=EC0751SSSZ5&-_lang=en.
10 47 CFR Part 90.
11 13 C.F.R. § 121.201 NAICS code 334220.
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100 employees.12 Thus, under this size standard, the majority of firms can be considered small.
9. We do note, however, that the allocation for the twenty-four megahertz of spectrum in four
frequency bands for the Medical Device Radio Communications Service would be limited to use by
MMNs. To date no entities are producing MMNs on a commercial basis. However, one entity, the
Alfred Mann Foundation (AMF), has produced prototype MMN devices. We have no data on the size of
AMF in terms of number of employees or revenue, but we presume that AMF is a small entity. In
general, there are only a small number of manufacturers who produce wireless implanted medical devices
(less than ten), and FDA approval must be secured before such devices are brought to market. Due to the
stringent FDA approval requirements, the small number of existing medical device manufacturers tend to
focus very narrowly on this highly specialized niche market.

D. Description of Projected Reporting, Recordkeeping, and Other Compliance

Requirements for Small Entities

10. The R&O adopts no reporting or record keeping requirements. However, the R&O does
adopt a number of service and technical rules that apply to all entities who manufacture and use MMN
devices in the four frequency bands. Under the adopted rules the MMNs will not require individual
licenses but instead will qualify for license-by-rule operation13 pursuant to Section 307(e) of the
Communications Act (Act).14 The rules generally require that MMNs be able to operate in the presence
of other primary and secondary users in these frequency bands.15 MMNs must be capable of operating on
any of the four allocated frequency bands.16 The programmer/controller (P/C) in the MMN will be
required to monitor the frequency band in which the MMN is operating at least once a second and must
monitor the other frequency bands often enough that when it does switch frequency bands it has
monitored the band it is switching to in the two seconds prior to switching.17 The P/C must be capable of
determining when either direction of the communication link between the P/C and the implanted devices
is becoming degraded to the extent that communication is likely to be lost for more than 45 milliseconds.
When the P/C makes this determination the MMN is required to move to another frequency band. The
P/C will also be required to switch to another frequency band if during the monitoring of the occupied
frequency band it determines that there is a received signal with power greater than -60 dBm in any 12.5
kHz bandwidth that persists for at least fifty milliseconds.18 The MMN transmitters must incorporate a
programmable means to implement a system shutdown process within 45 milliseconds of a
communication failure or on command from the P/C.19
11. MMN use shall be restricted for use by persons only for diagnostic and therapeutic purposes
and only to the extent that such devices have been provided to a human patient under the direction of a


12 See http://factfinder.census.gov/servlet/IBQTable?_bm=y&-geo_id=&-fds_name=EC0700A1&-_skip=4500&;-
ds_name=EC0731SG3&-_lang=en
13 See 47 C.F.R.§ 95.1201.
14 Under Section 307(e) of the Act, the Commission may authorize the operation of radio stations by rule without
individual licenses in certain specified radio services when the Commission determines that such authorization
serves the public interest, convenience, and necessity. The services set forth in this provision for which the
Commission may authorize operation by rule include: 1) the Citizens Band Radio Service; 2) the Radio Control
Service; 3) the Aviation Radio Service; and 4) the Maritime Radio Service. See 47 USC § 307(e)(1).
15 See paragraph 56, supra.
16 See paragraph 57, supra.
17 See paragraph 59, supra.
18 See paragraph 60, supra.
19 See paragraph 61, supra.
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duly authorized health care professional.20 P/Cs in different MMNs may communicate with each other
for the purposes of coordination of the use of the spectrum resource.21
However, P/Cs may not
communicate with non-implanted devices for other purposes.22
Implanted MMN devices may not
communicate directly with other MMN implanted devices. Multiple MMNs may be present within one
patient with each MMN having its own P/C.23 However, a P/C may not control implanted devices in
multiple patients.
12. MMNs may transmit in a maximum emission bandwidth of six megahertz. MMN
transmitters may transmit with a maximum EIRP of lesser of 1 mW or (10 log B – 7.782) dBm where B is
the 20 dB emission bandwidth of the transmitted signal in MHz.24 The P/C of an MMN may transmit
with a maximum duty cycle of 3 percent.25 The MMN must meet specific limits on both in-band and out-
of-band emissions.26
13. MMN transmitters will be required to maintain a frequency stability as specified in the
current MedRadio rules of +/- 100 ppm of the operating frequency over the range: (1) 25°C to 45°C in the
case of MMN implant transmitters; and (2) 0°C to 55°C in the case of MMN programmer/control
transmitters.27
14. MMN transmitters must be certificated except for such transmitters that are not marketed for
use in the United States, are being used in the United States by individuals who have traveled to the
United States from abroad, and comply with the applicable technical requirements.28 MMNs may be
operated anywhere that CB station operation is authorized under § 95.405 and not be required to transmit
a station identification announcement.29 All non-implanted MMN transmitters must be made available
for inspection upon request by an authorized FCC representative. Manufacturers of MMN transmitters
must include with each transmitting device a disclosure statement and each MMN programmer/controller
must be labeled with a statement.30 MMN transmitters must be labeled with a serial number, but this
serial number may be placed in the instruction manual for the transmitter in lieu of being placed directly
on the transmitter.31

E. Steps Taken to Minimize Significant Economic Impact on Small Entities, and Significant

Alternatives Considered

15. The RFA requires an agency to describe any significant alternatives that it has considered in
developing its approach, which may include the following four alternatives (among others): “(1) the
establishment of differing compliance or reporting requirements or timetables that take into account the


20 See paragraph 65, supra.
21 See paragraph 67, supra.
22 See paragraph 68, supra.
23 See paragraph 70, supra.
24 See paragraph 79, supra.
25 See paragraph 81, supra.
26 See paragraph 82, supra.
27 See paragraphs 83-84, supra.
28 See paragraph 89, supra.
29 See paragraph 89, supra.
30 See paragraph 92, supra.
31 See paragraph 93, supra.
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resources available to small entities; (2) the clarification, consolidation, or simplification of compliance
and reporting requirements under the rule for such small entities; (3) the use of performance rather than
design standards; and (4) an exemption from coverage of the rule, or any part thereof, for such small
entities.”32
16. We are adopting a license-by-rule approach for MMN operations. This should decrease the
cost of MMN use for small entities as compared to a licensing approach because they will not be subject
to the expense of obtaining a license.
17. We have adopted a requirement that MMNs be capable of operating in any of the four
allocated frequency bands. We do not believe this requirement will increase the cost of equipment
unreasonably or be burdensome for manufacturers to meet. We note that these four bands are relatively
close in frequency and thus only a single transmitter and one antenna are necessary to cover these four
bands. We believe that the components to enable manufacturers of MMNs to meet this requirement
should be readily available since equipment is currently designed to operate across the Federal mobile
bands between 406.1 MHz and 450 MHz and non-Federal mobile bands between 450 MHz and 512 MHz.
18. As described above we have adopted requirements that the P/C of an MMN monitor the
frequency bands and switch frequency bands under certain circumstances. We considered not imposing
any frequency monitoring requirements on MMNs. However, we believe that this requirement is
necessary because MMNs will operate in frequency bands where other services will operate on a primary
basis. The MMNs must therefore be capable of detecting signals from these other services and taking
steps to minimize the effects of these signals on MMN operations or switching frequency bands. Because
MMNs will be used for medical purposes, they must be reliable and therefore these frequency monitoring
requirements are necessary. We do not believe this monitoring requirement will add significant cost to
MMN equipment since radios now operating in these bands also have a requirement to monitor channels
prior to transmitting on them.33
19. The requirement that MMN transmitters maintain a frequency stability of +/- 100 ppm will
not impose significant costs on small entities because oscillators that meet this standard are readily
available.
20. We have adopted various provisions regarding equipment certification, authorized locations,
station identification, station inspection, disclosure policy, labeling requirements and marketing
limitations that mirror the existing MedRadio rules. We note that the certification and inspection
requirements apply to a broad range of wireless devices within the Commission’s jurisdiction and are a
necessary part of insuring that the Commission’s technical rules are followed. We therefore did not
consider alternatives to these requirements. The disclosure and labeling requirements inform interested
parties about limitations on use of the MMN devices, such as the fact that they may not cause interference
to and must accept interference from other stations operating on a primary basis in these bands. We
therefore believe that the disclosure and labeling requirements are useful and that they will not have a
significant cost. The marketing limitation permits MMNs to be marketed and sold only for the types of
communication that are permitted under the rules the Commission has adopted. We do not believe this
will impose significant costs on small entities.
21. Report to Congress: The Commission will send a copy of the Report and Order, including
this FRFA, in a report to Congress pursuant to the Congressional Review Act.34 In addition, the


32 5 U.S.C. § 603(c)(1) – (c)(4).
33 See paragraph 59, supra.
34 See 5 U.S.C. § 801(a)(1)(A).
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Commission will send a copy of the Report and Order, including this FRFA, to the Chief Counsel for
Advocacy of the SBA. A copy of the Report and Order and the FRFA (or summaries thereof) will also be
published in the Federal Register.35


35 See 5 U.S.C. § 604(b).
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STATEMENT OF

CHAIRMAN JULIUS GENACHOWSKI

Re:

Amendment of Parts 2 and 95 of the Commission’s Rules to Provide Additional Spectrum for


the Medical Device Radiocommunication Service in the 413-457 MHz band, ET Docket No.
09-36

This may seem like science fiction, but it’s not. A veteran who recently participated in a study
conducted at the Walter Reed Medical Center had a spinal cord injury that paralyzed his lower limbs. The
patient was treated with an early version of the technology we are further advancing today, Medical
Micropower Networks. Thanks to this technology, the patient recovered use of his limbs, and five months
later he could perform rehabilitation exercises without using the microstimulators.
Anyone wondering why we have made unleashing mobile innovation one of the FCC’s highest
priorities need look no further than this example, testimonials included in the record in this proceeding,
and the stories we heard in the video during the Bureau’s presentation. As we saw, new wireless networks
have the potential to enable paraplegics to stand and to facilitate other breakthrough treatments for
victims of spinal cord injuries, traumatic brain injuries, and strokes. These broadband-enabled
technologies are life-changing, impacting individuals, families, and communities in ways we can only
begin to imagine.
This may be the most dramatic step we've taken to harness the benefits of communications
technology for health care, but it's not the first. In our National Broadband Plan we identified health care
as an enormous area of opportunity. We pointed to ways that broadband can improve health care quality
and reduce costs – including remote medical monitoring. Wireless devices can help diabetes patients track
their glucose levels or heart disease patients monitor cardiovascular data.
And as part of our mobile broadband agenda, the Commission has already taken a number of
actions to seize the opportunities of mHealth. We entered an unprecedented partnership with the Food and
Drug Administration to help ensure that communications-related medical innovations can swiftly and
safely be brought to market. We’ve also taken steps to facilitate spectrum sharing and to improve and
expand our experimental licensing program, proposing to ease testing restrictions on universities and
research organizations, and proposing a new program to speed development of new health-related devices
that use spectrum.
Today’s order to enable Medical Micropower Networks builds on this work and promises to
dramatically improve the lives of the millions of Americans who suffer from spinal cord injuries,
traumatic brain injuries, strokes, and various neuromusculoskeletal disorders. These debilitating injuries
severely impair quality of life and impose significant medical costs. Americans incurred costs of
approximately $73.7 billion in 2010 for stroke-related disabilities and $60 billion in 2000 for traumatic
brain injuries. Of course, the true cost of these injuries to these victims is immeasurable.
The devices that we expect to be deployed under the rules the Commission adopts today hold the
promise of safer, less invasive, and more effective treatment options than those available under current
medical practice. We’re talking about medical miracles: allowing paraplegics to stand and restoring hand
grasp function for quadriplegics. The implications for veterans, accident victims and people born with
disabilities are incredible. Medical Micropower Networks can restore their mobility.
Medical Micropower Networks have been shown to reliably operate in spectrum shared with
other services and are a model for making more efficient use of radio spectrum by using advanced
technologies such as monitoring the quality of the radio link, switching frequency bands, notching out of
interfering signals, and error correction coding. Testing also demonstrates that the Medical Micropower
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Network devices developed by the Alfred Mann Foundation are able to operate reliably in spectrum
shared with federal government and commercial services.
The Commission’s action today is only a first step in our efforts to advance the health care
agenda. Early next year, I expect that we will act with respect to Medical Body Area Networks for
wireless patient monitoring in health care facilities and make changes to our experimental licensing
program to facilitate research and development of wireless medical devices.
I’m also pleased to announce that today the FCC’s Office of Engineering and Technology is
issuing an order allowing Second Sight Medical Products, Inc. to market a retinal prosthesis that will help
restore functional sight for individuals with certain eye diseases. Second Sight’s Argus II retinal
prosthesis is a medical implant system designed to treat blind people suffering from advanced retinal
degenerative diseases. The system consists of a neurostimulator surgically implanted on the eye, a pair of
eyeglasses housing a miniature video camera, and an external video processing unit connected to the
eyeglasses via cable.
The video camera captures images that are converted into instructional signals by the video
processing unit and are sent back to the eyeglasses to be wirelessly transmitted to the implant. OET’s
order will permit the device to exceed the Part 15 limits for intentional radiators when the data signals are
transmitted from the eyeglasses to the implant.
Helping a blind person to see. Empowering a paraplegic to stand. That’s the power of wireless
technology. And that’s why the FCC will continue working around the clock to harness this power to
improve the lives of the American people.
I want to recognize and thank the staff in our Office of Engineering and Technology who worked
on today’s item, particularly Julie Knapp, Geraldine Matise, Jamison Prime, Nicholas Oros and Peter
Georgiou. I’d also like to thank Amy Levine of my office for her excellent work shepherding through this
item.
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STATEMENT OF

COMMISSIONER MICHAEL J. COPPS

Re:

Amendment of Parts 2 and 95 of the Commission’s Rules to Provide Additional Spectrum for the


Medical Device Radiocommunication Service in the 413-457 Band

, ET Docket No. 09-36
Discussions of spectrum use can sometimes get a little abstract and hung up on issues like
competition, data rates, and interoperability. But every once in a while—and today is one of those “once
in a whiles”—we get a chance to talk about improving everyday lives in really direct ands meaningful
ways.
I am pleased - more than pleased—delighted—that we are taking action that will dramatically
improve the lives of potentially very many of our sisters and brothers who suffer from neuromuscular
disorders. The devices we help enable today can serve as artificial nervous systems to restore sensation,
mobility, and function to paralyzed limbs and organs, traumatic brain injury, stroke, cerebral palsy, and
multiple sclerosis.
Today’s action allocates 24 megahertz of spectrum in four band segments for the MedRadio
service on a secondary basis. The band here—400 MHz—is well suited for propagation inside the body.
These devices employ the latest techniques for efficient use of spectrum and interference mitigation—
tools like spectrum sensing and dynamic frequency selection. The devices’ low power means that they
themselves won’t pose interference to their neighbors. So there is a lot to like about today’s order—the
good it will do to restore critical functions for the injured, the innovative interference mitigation
techniques, and the strong federal coordination with our partners at NTIA and the Joint Spectrum Center.
I salute the Alfred Mann Foundation for its work with the Veterans Administration and other
hospitals under its experimental license, and its exhaustive research that has paved the way for our action
today.
My hope and expectation is that we will soon build on today’s action by addressing related
proposals for Medical Body Area Networks which have the capability to track peoples’ health status and
which can prove hugely helpful in a number of scenarios, one such being emergency situations.
I want to pay special thanks to my friend, Commissioner McDowell—and salute him—for the
leadership role he performed in getting this item moving initially. We wouldn’t be here doing this
without him. It was an item he brought to my attention as soon as I became Acting Chairman back in
2009 and together we got it teed up then. I also thank the Chairman for following through and getting us
to the finish line this morning, and other colleagues past and present who helped move it along in the
interim. Thanks in addition to Julie Knapp and his talented team for putting together such a welcome and
thorough Order that will no doubt change many lives for the better for years to come.
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STATEMENT OF

COMMISSIONER ROBERT M. McDOWELL

RE:

Amendment of Parts 2 and 95 of the Commission’s Rules to Provide Additional Spectrum for
the Medical Device Radiocommunication Service in the 413-457 Band

, ET Docket No. 09-36
Today’s Commission action represents the best of government performing a core mission:
helping others in need. Sadly, it has taken the government far too long to act in this important
proceeding. Regrettably, bureaucratic delay literally forced disabled patients to wait much longer than
necessary to benefit from some amazing emerging technologies. Nonetheless, I have had the privilege to
work closely with the Alfred Mann Foundation (AMF) throughout this challenging process on the
regulatory aspects of its groundbreaking research, and I am delighted that this day has finally come.
Neuromuscular injuries and disorders impose tremendous physical, psychological and financial
burdens. After years of investment and research, AMF produced remarkable technologies that allow
paralyzed people to regain use of their limbs. Such a vision was imaginable only in the texts of science
fiction a few years ago. Yet AMF has made it a reality for stroke victims, people paralyzed in accidents
and America’s wounded veterans.
AMF’s miraculous inventions, however, require low power use of specific wireless frequencies;
hence, the need for government approval. From a technical standpoint, we are implementing a sharing
technique that maximizes efficiency and employs spectrum in a dynamic manner, important policies for
which I have advocated for some time. It has been a lengthy process, yet worth the wait – AMF is poised
to revolutionize medical treatments and therapies to improve the lives of millions of people, and to bring a
measure of comfort and peace of mind to their families and friends.
Congratulations to AMF for its perseverance and commitment. Thank you to Chairman
Genachowski for bringing this order to a vote and also to then-Acting Chairman Copps for moving
forward on the notice of proposed rulemaking after an unnecessarily lengthy delay. I remember vividly
our conversation in January of 2009 that led to this day. So thank you for your leadership. Thank you
also to our dedicated and talented Office of Engineering and Technology staff for your important work.
Most importantly, congratulations to the paralyzed patients who now have more than hope to
support them – they will have the power of their own bodies. To you I also offer the apology of your
government for consuming nearly half a decade to reach this point.
55

Federal Communications Commission

FCC 11-176

STATEMENT OF

COMMISSIONER MIGNON L. CLYBURN

RE:

Amendment of Parts 2 and 95 of the Commission’s Rules to Provide Additional Spectrum for
the Medical Device Radiocommunication Service in the 413-457 Band

, ET Docket No. 09-36
One of this Commission’s key goals is to remove unnecessary regulatory barriers to the
development and deployment of products and services that have the potential of improving the lives of the
people we serve. So often, when we make substantial strides in this direction, that action fails to receive
the level of attention it deserves, because it seems difficult to construct a flashy headline, or hard to
generate the type of controversy which would carry on into another news cycle. But in my opinion, this
Order is one of the most important the Commission has adopted during my tenure, because the innovation
it unleashes—medical micro power networks—has the potential to greatly improve the lives of those who
are faced with some of today’s most difficult medical challenges.
In 2009, the Christopher and Dana Reeve Foundation published a report estimating that 5.6
million Americans suffer from some form of paralysis. The medical micro power networks, which the
Alfred Mann Foundation has developed, use implant devices to employ micro-stimulation techniques that
can restore sensation, mobility, and other vital functions, to limbs and organs. This is an exciting
innovation that could lead to incredible breakthroughs for the millions of Americans that suffer from
paralysis and other debilitating neuromuscular injuries or disorders. As the Order explains, the beneficial
impact of these micro-power networks could also reach beyond the medical field. Because of the
growing demand for wireless spectrum, we must promote more efficient use of allocated spectrum, and as
the Notice of Inquiry this Commission adopted last November makes clear, dynamic spectrum use
technologies could greatly advance this policy goal. Because the micro power networks leverage
advanced spectrum use technologies, such as spectrum sensing and dynamic frequency location, they are
also providing another business case for use of dynamic spectrum technologies.
But this technological innovation did not come easy or cheap. The Alfred Mann Foundation has
already spent approximately 115 million dollars and it has taken eleven years to develop this technology.
I commend the ingenuity, effort, and sacrifice that were necessary to create these important medical
treatment devices and services. And I wish to take another opportunity to applaud Julie Knapp, and the
talented OET staff, for working through the technical issues in this proceeding.
This day also represents an opportunity to highlight the potential the relevant federal agencies
have to ensure efficient approval of important technological innovations in the future. For example, the
Alfred Mann Foundation had to receive the necessary federal regulatory approvals not only from the
FCC, but also from the Veterans Administration, NTIA, and several agencies in the Department of
Defense at a cost of millions of dollars in administrative expenses. Enhanced interagency collaboration
has the potential to reduce the time and the economic resources it takes get such a valuable product on the
market, and I am looking forward to being a part of an ever-improving collaborative engagement. That is
why I was particularly pleased that last November, the FCC initiated a rulemaking proceeding, on the
medical program experimental licenses, which seeks to promote ways that the FCC, and other relevant
federal agencies, can help speed the development and deployment of wireless medical services to
consumers. I encourage the industry to provide us with a clear record on how we can further improve in
this area.
So this is a good news day, a significant news day for the FCC, as the Commission is taking an
affirmative measure to reduce barriers to deploy new wireless medical services and improve the lives of
millions.
56

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