Medimetrics Personalized Drug Delivery B.V., Part 15 Waiver Request
Federal Communications Commission
News Media Information 202 / 418-0500
445 12th St., S.W.
Washington, D.C. 20554
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
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
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
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.
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
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,
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Parties should also send a copy of their filings to Aamer Zain, Office of Engineering and Technology,
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Office of Engineering and Technology contact: Aamer Zain at (202) 418-2437.
By the Chief, Office of Engineering and Technology
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