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Medimetrics Personalized Drug Delivery B.V., Part 15 Waiver Request

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Released: June 4, 2014
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PUBLIC NOTICE

Federal Communications Commission

News Media Information 202 / 418-0500

445 12th St., S.W.

Internet: http://www.fcc.gov

TTY: 1-888-835-5322

Washington, D.C. 20554

DA 14-769

Released: June 4, 2014

OFFICE OF ENGINEERING AND TECHNOLOGY DECLARES THE MEDIMETRICS

REQUEST FOR A WAIVER OF PART 15 RULES FOR A MEDICAL DEVICE TO BE A

“PERMIT-BUT-DISCLOSE” PROCEEDING FOR EX PARTE PURPOSES AND REQUESTS

COMMENTS

ET Docket No. 14-84

Comment Date: July 7, 2014

Reply Comment Date: July 21, 2014

On March 19, 2014, Medimetrics Personalized Drug Delivery B.V. (Medimetrics) filed a request

for a waiver of Section 15.231(b) of the Commission’s rules to permit the marketing, sale and operation

of its medical device trademarked as “IntelliCap Portable Unit” (PU). Medimetrics states that the PU is

used to communicate data between a Central Control Unit (CCU), which is typically a laptop computer

loaded with proprietary software and an electronic capsule inserted in a human body for medication

purposes. The PU receives and relays from the capsule data indicating in real time the effectiveness of

medication. The PU communicates with the capsule in the 433 MHz band and with the CCU in the 2.4

GHz band. The waiver request applies only to IntelliCap FR Portable Unit used for drug development

research.

Section 15.231(b) defines the field strength of emissions from intentional radiators operating in

the band 40.66-40.70 MHz and above 70 MHz. It specifies that for the frequency band 260-470 MHz the

peak field strength limit range is 3750-12500 microvolts/meter, measured at a distance of 3 meters (linear

interpolation). In its waiver request, Medimetrics states that because the antenna on the capsule is not

optimal due to its size restriction, an increase in the PU transmit power is needed. The PU therefore

requires a waiver so that it can transmit control and synchronization signals with a peak power of 84304

microvolts, measured at 3 meters, to be able to reach the capsule through the human tissue. Medimetrics

states that the PU transmission time for each data stream will be less than 10.5 milliseconds and sent to

capsule not more than 5 times in a 72-hour period with at least several hours between each transmission.

The PU will be used in medical research environment only. Also in its request, Medimetrics clarifies that

PU receives transmission from the capsule in the 433 MHz band and relays it to a CCU using a 2.4 GHz

duplex link. These transmissions comply with Part 15 rules and therefore do not require a waiver of the

rules.

In its waiver request, Medimetrics contends that use of this medical system will be valuable tool

for research in pharmaceutical and food industries as it can provide real-time data for drugs and other

active substance when delivered in a controlled way within the gastro-intestinal tract.

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The FCC’s Office of Engineering and Technology (OET) is reviewing the waiver request. OET

has concluded that in order to develop a complete record on the complex issues presented by this request,

this proceeding will be treated, for ex parte purposes, as "permit-but-disclose" in accordance with Section

1.1200(a) of the Commission's rules, subject to the requirements under Section 1.1206(b).

Pursuant to sections 1.415 and 1.419 of the Commission’s rules, 47 CFR §§ 1.415, 1.419,

interested parties may file comments and reply comments on or before the dates indicated on the first

page of this document. Comments may be filed using: (1) the Commission’s Electronic Comment Filing

System (ECFS), (2) the Federal Government’s eRulemaking Portal, or (3) by filing paper copies. See

Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).

Electronic Filers: Comments may be filed electronically using the Internet by accessing the

ECFS: http://fjallfoss.fcc.gov/ecfs2/.

Paper Filers: Parties who choose to file by paper must file an original and one copies of each

filing. If more than one docket or rulemaking number appears in the caption of this proceeding,

filers must submit two additional copies for each additional docket or rulemaking number.

Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-

class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission’s

Secretary, Office of the Secretary, Federal Communications Commission.

All hand-delivered or messenger-delivered paper filings for the Commission’s Secretary

must be delivered to FCC Headquarters at 445 12th St., SW, Room TW-A325,

Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries

must be held together with rubber bands or fasteners. Any envelopes must be disposed of

before entering the building.

Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority

Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.

U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th

Street, SW, Washington DC 20554.

People with Disabilities: To request materials in accessible formats for people with disabilities

(braille, large print, electronic files, audio format), send an e-mail to fcc504@fcc.gov or call the

Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

All filings must be addressed to the Commission’s Secretary, Marlene H. Dortch, Office of the

Secretary, Federal Communications Commission, 445 12th Street, S.W., Washington, D.C. 20554.

Parties should also send a copy of their filings to Aamer Zain, Office of Engineering and Technology,

Federal Communications Commission, Room 7-A201, 445 12th Street, S.W., Washington, D.C. 20554,

or by e-mail to aamer.zain@fcc.gov. Parties must also serve one copy with the Commission’s copy

contractor, Best Copy and Printing, Inc. (BCPI), Portals II, 445 12th Street, S.W., Room CY-B402,

Washington, D.C. 20554, (202) 488-5300, or via e-mail to fcc@bcpiweb.com.

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Documents are available for public inspection and copying during business hours at the FCC

Reference Information Center, Portals II, 445 12th Street, S.W., Room CY-A257, Washington, D.C.

20554. The documents may also be purchased from BCPI, telephone (202) 488-5300, facsimile (202)

488-5563, TTY (202) 488-5562, e-mail fcc@bcpiweb.com.

Office of Engineering and Technology contact: Aamer Zain at (202) 418-2437.

By the Chief, Office of Engineering and Technology

-FCC-

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