Federal Communications Commission DA 07-801
Before the
Federal Communications Commission
Washington, D.C. 20554
In the Matter of
TRANSOMA MEDICAL, INC.
Request for Interpretation of Medical Implant 
Communications Service Rules
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ORDER
Adopted:  February 21, 2007 Released:  February 22, 2007
By the Deputy Chief, Mobility Division, Wireless Telecommunications Bureau:
1. Introduction.  We have before us a request1 from Transoma Medical, Inc. (Transoma), for 
declaratory ruling (Petition).2 Specifically, Transoma requests confirmation of its understanding that the 
rules governing the Medical Implant Communications Service (MICS)3 permit the use of MICS systems 
for drug testing by the pharmaceutical industry.  We deny the Petition for reasons discussed below.
2. Background. The Commission adopted rules establishing the MICS in 1999.4 The MICS 
was created in the 402-405 MHz frequency band as “an ultra-low power, unlicensed, mobile radio service 
for transmitting data in support of the diagnostic and/or therapeutic functions associated with implanted 
medical devices.”5 It was intended to accommodate “potential life-saving medical technology” while 
protecting other users of this spectrum from interference.6  Accordingly, Section 95.1209(a) of the 
Commission’s Rules provides that, “[e]xcept for the purposes of testing and for demonstrations to health 
care professionals, medical implant programmer/control transmitters may transmit only operational, 
diagnostic and therapeutic information associated with a medical implant device that has been implanted 
by a duly authorized health care professional.”7  
3. Transoma seeks confirmation of its understanding that MICS may be used “in medically 
related industries by the pharmaceutical industry for drug safety and efficacy monitoring and in research 
related to developing new therapies and physiological understanding of those therapies” for “monitoring 
physiological parameters of the being that is chosen as the subject of the experiment.”8  It argues that the 
use of MICS devices in such experiments is consistent with the goal underlying the establishment of the 
  
1 Letter dated March 13, 2006, from Perry Mills, Vice President and Chief Technology Officer, Transoma Medical, 
Inc., to Catherine W. Seidel, Acting Chief, Wireless Telecommunications Bureau (Petition).
2 See 47 C.F.R. § 1.2.
3 See 47 C.F.R. §§ 95.1201-95.1219.
4 See Amendment of Parts 2 and 95 of the Commission’s Rules to Establish a Medical Implant Communications 
Service in the 402-405 MHz Band, Report and Order, WT Docket No. 99-66, 14 FCC Rcd 21040 (1999), corrected 
by Errata, 15 FCC Rcd 12387 (2000) (MICS Report and Order).
5 Id. at 21040 ¶ 1.
6 Id.
7 47 C.F.R. § 95.1209(a).
8 See Petition at 1.  We understand Transoma to be requesting confirmation that the MICS devices can be used for 
drug testing on animals as well as human beings.
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MICS, to enhance the health and quality of life of medical patients, because the devices would be used to 
develop “new pharmaceuticals and therapies that may ultimately be used by physicians everywhere.”9  
Transoma states that it envisions developing products that are fully compliant with the MICS technical 
requirements, including the capability of using listen-before-talk and adaptive frequency agility 
techniques to avoid causing or receiving interference from other users of the 402-405 MHz band.10  
4. Discussion.  We deny the Petition.  The MICS rules clearly contemplate that MICS 
devices will be used solely for the medical treatment of individual patients by licensed health care 
providers.  The MICS is expressly restricted to use in support of “diagnostic” and “therapeutic” 
functions.11 The terms “diagnostic” and “therapeutic” clearly refer in this context to a physician’s or 
other licensed health care provider’s use of MICS transmitters to diagnose, monitor and treat conditions 
of individual patients. Throughout the rulemaking proceeding establishing the MICS, moreover, the 
service was repeatedly described as one intended to enhance the medical treatment of individual 
patients.12  In addition, we note that the rules expressly refer only to implantation of MICS devices in 
humans.13 Had the Commission intended to authorize other uses of MICS devices, such as to facilitate 
  
9 See id. Transoma also states that the use of its MICS units in drug experiments “would typically be under the 
direction and control of duly authorized medical professionals.”  Id.
10 Id.  Implanted MICS devices may transmit in two circumstances.  First, implanted MICS devices may transmit in 
response to a transmission from an external medical implant programmer/control transmitter or a non-radio 
frequency actuation signal generated by an external device.  See 47 C.F.R. § 95.1209(b).  The external medical 
implant programmer/control transmitter must follow a listen-before-talk protocol before transmitting to ensure that a 
selected channel is not already occupied.  See 47 C.F.R. § 95.628.  The second circumstance in which an implanted 
MICS device may transmit is in response to a “medical implant event.”  See 47 C.F.R. § 95.1209(b).  A medical 
implant event is “[a]n occurrence or the lack of an occurrence recognized by a medical implant device, or a duly 
authorized health care professional, that requires the transmission of data from a medical implant transmitter in order 
to protect the safety or well-being of the person in whom the medical implant transmitter has been implanted.”  See
47 C.F.R. Part 95, Subpart E, Appendix 1 - Glossary of Terms.
11 See MICS Report and Order, 14 FCC Rcd at 21040 ¶ 1; 47 C.F.R. § 95.1209(a).  Although Section 95.1209(a) 
also refers to the transmission of “operational” information as well as “diagnostic and therapeutic” information, this 
additional modifier cannot be read as authorizing the use of MICS in drug testing, but rather as reflecting that the 
rule authorizes operation of MICS devices in demonstrations to health care professionals and for testing the 
operation of the devices. 
12 See, e.g., Amendment of Parts 2 and 95 of the Commission’s Rules to Establish a Medical Implant 
Communications Service in the 402-405 MHz Band, Notice of Proposed Rule Making, WT Docket No. 99-66, 14 
FCC Rcd 3659, 3661 ¶ 6 (1999) (noting that the Commission “anticipate[s] that medical implant devices developed 
under the MICS would provide a safer, less expensive, and less invasive method to diagnose and manage patient
conditions than the inductive systems now used”) (footnote omitted, emphasis added); id. at 3663-64 ¶ 10 (noting 
that an allocation of ten channels of 300 kilohertz each for MICS will, inter alia, “allow the system to avoid 
interference from other radio frequency devices that are used in clinical environments, and will help to protect 
patients from any jamming or data corruption occurring as a result of another device being within range of the 
implant”) (emphases added); MICS Report and Order, 14 FCC Rcd at 21042 ¶ 4 (noting, with tacit agreement, a 
commenter’s assertion that “the MICS would permit physicians and their patients to take advantage of the benefits 
of wireless technology to improve the medical care and capabilities of implanted medical devices, thereby 
improving these patients’ quality of life”) (emphasis added); id. at 21042 ¶ 5 (noting, with tacit agreement, other 
commenters’ statements that MICS would serve the public interest by enhancing patient care and treatment).
13 See 47 C.F.R. Part 95, Subpart E, Appendix 1 - Glossary of Terms (defining “medical implant event” as an 
occurrence that requires the transmission of data “in order to protect the safety or well-being of the person in whom 
the medical implant transmitter has been implanted,” “medical implant transmitter” as “[a] MICS transmitter that 
operates or is designed to operate within a human body for the purpose of facilitating communications from a 
medical implant device,” and “medical implant device” as an “[a]pparatus that is placed inside the human body for 
the purpose of performing diagnostic or therapeutic functions”) (emphases added).  We note that the Commission 
(continued....)
Federal Communications Commission DA 07-801 
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research and development by the pharmaceutical industry, we believe it would have done so expressly.14  
5. Transoma acknowledges that research and development applications could be outside the 
scope of the MICS rules “because the discussions surrounding MICS during the development of the 
rulemaking focused primarily on implants placed in patients for the purpose of improving their health and 
quality of life.”15 Transoma argues, however, that the proposed use of MICS devices in pharmaceutical 
studies could lead to the development of new therapies that “may have as great or even greater impact on 
the health and quality of life for a much larger patient base than usage in the classical sense of an 
implanted patient and as such these application should fall within the scope of the MICS rules.”16 We 
disagree.  The public interest benefits of extending the use of the MICS to medical research and 
development efforts is a matter that is properly considered in the rulemaking context, where those benefits 
can be weighed against other factors, such as the interference impact of such expanded use.  Whatever the
merits of such an expansion as a matter of policy (on which we express no view herein), it provides no 
basis for interpreting the MICS rules in a manner contrary to their plain language and the Commission’s 
plain intent in adopting the rules.
6. Conclusion. We conclude that the Commission’s rules authorize the use of MICS 
devices only for the diagnosis, monitoring and treatment of human patients, and that MICS devices may 
not be used in pharmaceutical research and development activities, such as testing the safety and efficacy 
of new drug protocols, that do not involve the treatment of patients.  We accordingly deny the Petition.
7. Accordingly, IT IS ORDERED, pursuant to Section 4(i) of the Communications Act of 
1934, as amended, 47 U.S.C. § 154(i), and Section 1.2 of the Commission’s Rules, 47 C.F.R. § 1.2, that 
the request for declaratory ruling filed by Transoma Medical, Inc. on March 13, 2006, IS DENIED.
8. This action is taken under delegated authority pursuant to Sections 0.131 and 0.331 of the 
Commission's Rules, 47 C.F.R. §§ 0.131, 0.331.
FEDERAL COMMUNICATIONS COMMISSION
Scot Stone
Deputy Chief, Mobility Division
Wireless Telecommunications Bureau
  
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selected the 402-405 MHz band for MICS operations due in part to its signal propagation characteristics in the
human body.  See MICS Report and Order, 14 FCC Rcd at 21042-43 ¶ 6.
14 See also Investigation of the Spectrum Requirements for Advanced Medical Technologies, Notice of Proposed 
Rulemaking, Notice of Inquiry, and Order, ET Docket No. 06-135, 21 FCC Rcd 8164, 8165 ¶ 1 (2006) (“In this 
proceeding, the Commission intends to modify its rules to accommodate the development and use of a variety of 
new medical devices that rely on radiocommunication for critical aspects of their functionality. . . . For health care
providers and patients, such wireless implant monitoring technologies have the potential to lower medical costs by 
extending the time between hospital visits and surgical procedures.”); id. at 8167 ¶ 7 (“The MICS service was 
anticipated to transmit data in support of the diagnostic and/or therapeutic functions associated with implanted 
medical devices to enable individuals and medical practitioners to utilize potential life-saving medical technology 
without causing interference to other users of the spectrum.”).
15 See Petition at 1.
16 Id.