**Before the**

**Federal Communications Commission**

**Washington, D.C. 20554**

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| In the Matter of                 | *  | ET Docket No. 05-213         |
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| DexCom, Inc .                    | ** |                              |
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| Request for Waiver of the        | *  |                              |
| Frequency Monitoring             | *) |                              |
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| Requirements for the Medical     |    |                              |
| Implant                          | *  |                              |
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| Communications Service Rules     | ** |                              |
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**ORDER**

**Adopted: January 12, 2006 Released: January 18, 2006**

By the Commission:

# INTRODUCTION

1.  By this Order, we grant a request for waiver filed by DexCom,
    Inc.,[^1] authorizing it to build and market its blood glucose
    monitoring system to operate in the Medical Implant Communications
    Service (MICS) band.[^2] This waiver is granted for a period of
    three years, or until such time as the Commission amends its rules
    related to such devices to obviate the need for a waiver or to
    specify rules with which devices of this kind will be required to
    comply.

2.  The DexCom STS (short-term) and LTS (long-term) blood glucose
    monitoring sensors are devices implanted into the body that combine
    a monitor with a low-power transmitter to provide frequent, periodic
    information regarding blood glucose levels. These monitor readings
    are transmitted to a receiver worn by a diabetic patient, so that
    the patient can continuously monitor his/her blood glucose level and
    take nutrition or medication (insulin) as necessary to maintain an
    appropriate glucose level in the blood. They can also send an alarm
    to the wearer when the blood glucose level falls outside acceptable
    levels. The devices operate on a single channel, and do not have a
    "listen before talk" (LBT) capability nor are they frequency agile,
    as required by the MICS rules.[^3] Consequently, DexCom requests a
    waiver of these rules to permit it to manufacture and market, and
    for medical professionals to prescribe and diabetic patients to use,
    the STS and LTS as currently configured.

3.  Opposition was filed by Medtronic, Inc. (Medtronic), the developer
    of a variety of medical implant devices, including implanted
    monitoring and communications devices for cardiac patients that
    comply fully with the MICS rules.[^4] Comments supporting DexCom's
    request were filed by the Juvenile Diabetes Research Foundation
    (JDRF); Biotronik, a maker of other implantable medical devices with
    transmitters; and AMI Semiconductors, Inc. (AMI), a provider of
    integrated circuits to the medical industry.

# BACKGROUND

4.  In 1999, the Commission established the MICS rules to allow the
    operation of radio transmitters that support 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.[^5] The Commission determined that the
    402-405 MHz band is particularly well suited for this service, due
    to the signal propagation characteristics in the human body, the
    relative dearth of other users of the band, the compatibility of the
    MICS service with the incumbent users of the band, and its use
    internationally for this purpose.[^6] To avoid harming other users
    of the frequency band, MICS was provided a secondary allocation. The
    402-405 MHz band was, and remains, allocated on a primary basis to
    Federal Government uses, including Meteorological Aids Service
    (Metaids), the Meteorological Satellite Service, and the Earth
    Exploration Satellite Service.[^7] The Commission adopted technical
    rules for the MICS specifically designed to protect these incumbent
    Federal services, as well as to ensure compatibility among multiple
    MICS devices and users.[^8] These rules establish a channel
    bandwidth of 300 kHz for this service within the allotted
    bandwidth,[^9] provide for frequency sharing and cooperation in the
    selection and use of channels,[^10] and establish specific
    guidelines for frequency monitoring prior to transmission by implant
    programmer/control transmitters.[^11] [^12] Given these protections,
    the National Telecommunications and Information Administration
    (NTIA), representing the incumbent Federal user entitled to
    exclusive use of this band, interposed no objection to this
    allocation.[^13]

5.  In 2003, the Commission found that another implanted medical device
    (a cardiac pacemaker with a transmitter for monitoring data
    concerning the heart) that operates similarly to the subject devices
    -- at very low power with periodic, brief transmissions in the MICS
    band, lacking a listen-before-talk function and frequency agility --
    did not comply with the Commission's rules when sending regular,
    pre-programmed transmissions.[^14] Subsequently, however, the
    Commission granted a temporary waiver for this device, finding that
    the device could not be made to comply with the MICS rules and still
    effectively serve patients at that time or in the near future, and
    that the minimal risk of harmful interference to or from the device
    was outweighed by the significant medical benefits that the device
    could immediately provide with existing technology.[^15]

6.  On July 15, 2005, Medtronic filed a Petition for Rulemaking
    proposing that a new Medical Data Service (MEDS) be established to
    operate on a secondary basis on spectrum adjacent to the MICS
    spectrum, to accommodate simple implanted and body-worn medical
    devices that are transmit-only and are not frequency agile. The
    Commission has issued a public notice seeking comment on that
    proposal.[^16]

# PLEADINGS

7.  DexCom states that diabetes is a serious and costly health problem
    in the United States and worldwide. It contends that maintaining the
    proper blood glucose level is a critical element in controlling
    diabetes, and that a number of factors, anticipated and
    unanticipated, can affect blood glucose, so that constant monitoring
    is a necessary prerequisite for proper maintenance. It notes that
    monitoring is currently performed by a patient sticking his/her
    finger to draw a small amount of blood for testing, and asserts that
    this method is inconvenient, painful, and difficult to conduct and
    interpret properly. DexCom submits there is a great public need for
    implantable blood glucose sensors which can provide continuous,
    reliable blood glucose information to help each patient monitor
    his/her condition, and manage his/her diet, activity, and medication
    accordingly.

8.  DexCom states that the STS and LTS[^17] are designed to provide this
    continuous monitoring function. These implant devices include
    sensors that obtain blood glucose measurements and transmit them
    every five minutes to a receiver carried by the patient. A patient
    can, at any time, access information on his/her current blood
    glucose level and a chart of recent levels, to determine not only
    the current level but also how well the blood glucose level is being
    maintained. In addition, an alarm will sound with each periodic
    transmission when blood glucose becomes too high or too low, and
    repeat with each subsequent periodic transmission until the
    condition is corrected. DexCom claims that clinical studies show
    that its monitoring system increases the amount of time that a
    patient spends at his/her target blood glucose level by 88%.

9.  DexCom asserts that there is no realistic chance of interference
    from or to the DexCom STS and LTS devices. It states that the
    devices operate at very low power levels, peaking at approximately
    -20dBm conducted, for an operating range of approximately five feet,
    and that they transmit on a single frequency and for only 6-9
    milliseconds every five minutes. Accordingly, DexCom argues, there
    is virtually no chance of interference to other MICS devices. In
    addition, DexCom states that its system includes cyclic redundancy
    and unique identification codes, and the receiver is on only when
    the transmitter is transmitting, so that the integrity of the data
    in each transmission is ensured. It relates that if a transmission
    is blocked or missed, that event is included in the data available,
    and any such isolated failures will not compromise the utility of
    the trend data in a manner that would seriously affect the health or
    safety of the user.

10. DexCom claims that a rule waiver is necessary in order to provide
    this therapeutic tool to diabetics because technology does not exist
    to allow it to create an effective and practical system that
    incorporates LBT technology in these devices. According to DexCom,
    the unidirectional circuitry of the STS and LTS allows for a compact
    implant design which makes the device more readily implantable and
    more stable when implanted, as is critical for accurate reading of
    blood glucose levels. DexCom also states that this design,
    importantly, provides for a longer battery life, a critical factor
    for an implantable device.

11. Dexcom contends that a waiver would be consistent with the
    underlying purpose of the MICS rules, which it characterizes as
    making the diagnostic and therapeutic benefits of medical implant
    devices available to the public while avoiding harmful interference.
    In this regard, DexCom cites the prior grant of a waiver by the
    Commission to Biotronik for cardiac implant devices to operate using
    periodically scheduled transmissions without a LBT capability.[^18]
    DexCom appends letters avowing the benefits of the STS and LTS
    devices from Dr. Lois Jovanovic of the the Sansum Diabetes Research
    Institute at the University of California at Santa Barbara, from Dr.
    Steve Edelman of the Veterans Affairs Medical Center at the
    University of California at San Diego, and from Dr. Sherwyn
    Schwartz, founder and medical director of the Diabetes and Glandular
    Disease Clinic of San Antonio, Texas. Each of these doctors
    describes his/her extensive experience and expertise in the fields
    of diabetes research and treatment, and attests to DexCom's claims
    as to the critical importance of regular blood glucose monitoring in
    controlling diabetes, and the desirability of a device such as the
    STS or LTS to accomplish this.

12. In support of the waiver request, the JDRF underscores the potential
    for positive impact that continuous glucose sensing technologies may
    have for diabetes patients, and asserts that a number of studies
    have shown that tighter glucose control can reduce the costly and
    debilitating complications associated with diabetes. Biotronik also
    asserts that the DexCom devices can improve the well being of
    millions of Americans, and agrees with DexCom that there is no
    potential for interference between the subject devices and other
    MICS users. It contends that a LBT function cannot be achieved
    without significant sacrifice to both battery longevity and the size
    of the device, and that each of these design considerations are
    critical for implantable medical devices. AMI also asserts that
    DexCom's implantable continuous glucose monitoring system provides
    significant medical benefits. As a provider of specific integrated
    circuits and standard products to the medical marketplace, AMI
    insists that such frequent monitoring imposes demands on the battery
    that are inconsistent with a LBT protocol. A larger battery or more
    frequent surgeries, it surmises, will reduce the number of patients
    that will use such a device. It, too, concludes that the combination
    of low duty cycle, transmission time, and range should pose little
    risk of interference.

13. Medtronic opposes the waiver request, contending that a waiver is
    unnecessary, as other spectrum is available for this device that
    would permit it to operate within the Commission's rules. It also
    claims that other medical device manufacturers are developing
    products that comply with the rules, contrary to DexCom's claim that
    a rule waiver is necessary to design and manufacture suitable
    medical implant devices. It submits that ultra-low power MICS
    transceiver chips are now available from a number of sources, and
    that compliance with the LBT requirement is fully within the state
    of the art. It contends that grant of this waiver would compromise
    the integrity of the MICS service as more and more patients rely on
    intelligent medical implants to convey time-sensitive information.
    It also asserts that many international regulatory bodies call for
    smart radio technology for medical implant communications devices
    operating at 402-405 MHz, and that LBT is a cornerstone of the MICS.
    Medtronic also complains that DexCom's failure to disclose key RF
    system operating parameters or to provide a complete description of
    its sensor systems makes it impossible to assess fully the
    interference impact of the STS and LTS on other low-power medical
    devices, and asserts that the DexCom device would be subject to
    receiving interference. Medtronic also argues that the transmitter
    portion of the devices rests on top of the skin, and thus is not
    within the purview of the MICS rules. It urges the Commission, if it
    does grant a waiver, to require that DexCom use spectrum directly
    adjacent to the MICS spectrum, and proposes several conditions.
    Specifically, it asks that we limit the waiver to two years; that we
    apply it only to subcutaneous and transcutaneous equipment and
    exclude equipment that is entirely external to the body; that we
    limit operation to non-life-critical, non-emergency communications;
    that we require that medical professionals and patients be given
    prior notice of the potential of interference from Metaids
    radiosondes along with instruction on how to mitigate interference;
    and that we require system administrators to give medical
    professionals and patients notice of each of the conditions placed
    on the DexCom equipment. Medtronic notes that it has filed a
    petition for rulemaking to establish the Medical Data Service (MEDS)
    at 401-402 and 405-406 MHz for just such devices.[^19]

# discussion

14. We find that a temporary waiver for the DexCom STS and LTS to
    operate as currently designed is warranted. There is good cause for
    granting this waiver, and it is in the public interest to do
    so.[^20] To deny the waiver would frustrate the underlying purpose
    of the rules and DexCom and the diabetic patients its devices will
    serve have no reasonable alternative to obtain the important
    benefits afforded by the DexCom devices at this time.[^21] The
    periodic/automatic transmissions of the STS and LTS will assist
    diabetics in maintaining their blood glucose levels, a very
    significant therapeutic benefit that was a basis for the
    establishment of the MICS rules, without posing an undue potential
    for interference.[^22] This waiver is granted for three years, or
    until completion of any rule making the Commission may undertake,
    whichever is later. If rules are adopted with which the STS and LTS
    comply, the waiver will become moot. If rules are adopted that would
    require modifications to the STS and LTS, such as a change in power
    or frequency, DexCom will have one year from the effective date of
    such rules to bring its devices into compliance. In any event, any
    devices implanted pursuant to the instant waiver may continue
    operating until the end of their useful life.

15. The significant medical value of these devices as presently
    constituted for current diabetic patients is a compelling factor in
    our consideration. The substantial public interest in making a blood
    glucose monitoring system available is uncontested. According to the
    un-refuted statements of DexCom and its supporters in this waiver
    request, close to 20 million Americans and over 170 million people
    worldwide suffer from diabetes, and it is the fifth-leading cause of
    death by disease in the United States. Diabetes and complications
    from diabetes, including heart disease, stroke, loss of eyesight,
    loss of kidney function, and amputation of limbs, is presently
    estimated at \$132 billion per year, including \$90 billion in
    direct medical care costs. While there is no known cure for
    diabetes, a critical goal of medical care is to manage patients'
    blood sugar levels to control the disease. Regular monitoring is, in
    turn, a critical element of achieving this. Unfortunately,
    two-thirds of Type 2 diabetics[^23] in America do not have adequate
    control of their blood glucose levels. The importance of regular
    monitoring and maintenance is attested to by several experts in the
    field, and by several studies referred to by DexCom. In addition,
    DexCom has submitted data derived from clinical trials which compare
    the blood sugar levels of a patient using the traditional, and less
    frequent, "finger stick" method with the continuous data available
    from the DexCom system; this data demonstrate a dramatic improvement
    with continuous monitoring. We also take cognizance of DexCom's
    statement that the Federal Drug Administration is expediting its
    review of the devices in view of the health benefits they promise.

16. DexCom has also demonstrated that there is little risk of harmful
    interference caused by or occurring to the devices. While Medtronic
    charges that it does not have complete information regarding the RF
    characteristics of the devices, such as their exact power level, so
    as to assess their potential to interfere with MICS devices, we find
    the information available is sufficient to make this determination
    when considered in the light least favorable to DexCom. The STS and
    LTS will operate on only one frequency (402.142 MHz +/-40 kHz),
    occupying only 120 kHz of bandwidth, at a power level less than that
    permitted in the MICS band (-20dBm conducted),[^24] and for only 6-9
    milliseconds every five minutes. This combination of bandwidth,
    power, and duration make the likelihood of causing interference
    virtually nil. Given the proximity of the receiver to the
    transmitter, it is also highly unlikely that another MICS device
    will be sufficiently close to cause interference to a DexCom device
    while attempting to transmit at the same moment and on the same
    frequency as a DexCom device. The likelihood of interference to a
    DexCom receiver that would obstruct its basic function is even
    further remote, given the frequency of data transmissions and the
    non-critical nature of an individual transmission. If an undesired
    signal is received, the data will not be corrupted, but simply
    blocked from reception. If a transmission is not received due to
    interference, the loss of that data point, one of 288 per day, is
    not critical to the overall monitoring function provided by the
    monitor.[^25] If that particular reading or datum warrants an alarm,
    the alarm will be resent with each subsequent periodic transmission
    until the patient's blood glucose level returns to an acceptable
    level, and while prompt response by the patient is desirable, a
    delay of minutes is not critical. We note, too, that the National
    Telecommunications and Information Administration (NTIA), which
    represents the primary, licensed, users of this band and is
    concerned with any possible negative effects of its operation, has
    raised no objection to this waiver.

17. DexCom has also shown that a waiver of the MICS rules is necessary
    for its device to function effectively. The unidirectional circuitry
    of the device allows for a compact and lightweight design that will
    remain in place for accurate sensing, with a relatively long life.
    Moreover, keeping down the cost of the system will make it
    accessible to more users. While Medtronic asserts that compliant
    technology exists, the examples it provides are either not presently
    available or do not appear suitable for the device that DexCom has
    developed. The existence of a few other medical transmit devices
    that operate at other frequencies on an unlicensed basis does not
    undercut this conclusion. While there is other spectrum in which
    unlicensed devices can operate, the spectrum specifically suggested
    by Medtronic[^26] has restrictions that are inappropriate for the
    subject devices or are sufficiently congested to pose a risk that
    the very low powered transmissions of the subject devices would be
    at greater risk of receiving interference; moreover, they would have
    no interference protection from the plethora of other devices
    operating in those bands. Neither do we see a need to require DexCom
    to redesign its equipment to use alternative spectrum adjacent to
    the MICS spectrum, as suggested by Medtronic. Such a change would
    not obviate the need for a waiver and, as indicated above, we do not
    anticipate a realistic likelihood of interference, at least in the
    timeframe encompassed by this waiver. Moreover, given the potential
    for a rulemaking proceeding addressing medical telemetry devices and
    the spectrum at issue, it would be premature to move these devices
    off the frequency currently designated for medical implant
    communications.

18. Medtronic's argument that DexCom cannot invoke the MICS rules
    because the transmitter for the STS lies above the skin is
    unavailing. Section 95.1201 of our rules provides that "\[a\] person
    is permitted to operate medical implant transmitters connected to
    medical implant devices that have been implanted in that
    person...."[^27] The phrase "that have been implanted" can modify
    "medical implant devices" or it can modify "medical implant
    transmitters connected to medical implant devices." The text of the
    *MICS Order* is not conclusive in this regard. We do note that the
    term "medical implant transmitter" is defined as "\[a\] MICS
    transmitter that operates or is designed to operate within a human
    body..." in the appendix to subpart E of Part 95.[^28] In any event,
    DexCom is seeking waiver of the MICS rules, not to invoke the MICS
    rules, so that a determination of this issue is not required in
    order to grant the waiver request. We will clarify this issue in any
    future proceeding on medical implant devices.

19. Finally, most of the conditions sought by Medtronic are variously
    inappropriate or unnecessary. We reject Medtronic's request that we
    restrict the waiver to subcutaneous and transcutaneous transmitters
    for the reasons indicated above. We also reject its request for a
    two-year limit. Instead, we are making the waiver dependent on the
    timing and outcome of any relevant rule making we may conclude, with
    a minimum of three years as a reasonable timeframe for successfully
    marketing and implementing use of the subject devices in their
    current configuration. There is no evidence that the MICS band would
    become so congested in that time that the STS and LTS would pose an
    undue interference risk if the current rules are maintained.
    Moreover, this period will provide a better picture of the utility
    and interference potential of these devices should a dispositive
    rule making not conclude in the interim and a subsequent waiver be
    presented for consideration. Its proposed limitation regarding the
    devices' operational characteristics are necessarily observed in
    granting this waiver for the specific subject devices. Proposed
    warnings regarding potential interference from radiosondes are
    largely unnecessary, given the insignificance of such interference
    when it might occur. The other conditions we do impose (below) do
    not comprise pertinent information for medical professionals or
    patients using the subject devices.

20. We recognize here, as we did in granting the Biotronik waiver, that
    this waiver request and our action herein may presage a need or a
    reasonable desire for additional medical implant devices that would
    operate at variance with the current MICS rules.[^29] As noted
    above, we have very recently accepted comment on just such a
    proposal by Medtronic, and the waiver granted herein is subject,
    after a prescribed transition period to modification based on any
    rules we may adopt.

21. For the above reasons, we will grant this waiver for a period of
    three years, or until one year after completion of any rule making
    the Commission may undertake regarding medical implant devices,
    whichever is later. Additionally, we will condition the continued
    implantation of the devices covered by this waiver on their
    non-interference with other MICS devices and with the primary users
    of this spectrum. Should a pattern of interference develop that is
    traceable to devices operating pursuant to this waiver, we will
    rescind the waiver to prohibit the implantation of additional
    devices.[^30] This period of time should provide an adequate window
    for the successful manufacture and utilization of the subject
    devices while we contemplate changes to the medical implant rules.
    Also, during this period, advances in technology may improve the
    operability and availability of listen-before-talk implantable
    devices, obviating the need for a waiver for future devices.

    **V. ORDERING CLAUSES**

22. Accordingly, pursuant to Section 1.925 of the Commission's rules (47
    C.F.R. § 1.925), DexCom's petition for waiver of the MICS rules IS
    GRANTED for the manufacture and use of the STS and LTS blood glucose
    monitoring systems, as described in this Order, subject to the
    following conditions:

    Devices authorized by this waiver will:

    \(a\) Occupy no more than 120 kHz of bandwidth at 402.142 MHz +/- 40
    kHz;

    \(b\) Provide transmissions that do not exceed 10 milliseconds each;

    \(c\) Employ a duty cycle that does not exceed one transmission
    every five minutes;

    This waiver does not relieve DexCom of the requirement to avoid
    interference to other MICS devices and to the licensed primary users
    of this band.

    This waiver does not provide the subject devices with protection of
    transmissions by authorized users of the band.

    This waiver expires three years from the release date of this Order
    or until one year after completion of any rule making the Commission
    may undertake, whichever is later. After that time, LTS devices
    implanted pursuant to this waiver may continue to operate, but use
    of STS devices under this waiver must cease and no additional LTS
    devices can be implanted in patients pursuant to this waiver.

    FEDERAL COMMUNICATIONS COMMISSION

    Marlene H. Dortch Secretary

[^1]: Public Notice, June 15, 2005, DA 05-1670.

[^2]: MICS operates at 402-405 MHz, and is governed by Part 95, Subpart
    I of the Commission's rules (47 C.F.R §§ 95.1201ff; also 47 C.F.R. §
    95.628).

[^3]: 47 C.F.R. § 95.1211.

[^4]: Meditronic also makes insulin pumps and a monitor for diabetics
    that communicate on non-MICS frequencies.

[^5]: *Report and Order* in WT Docket No. 99-66 (Amendment of Parts 2
    and 95 of the Commission's Rules to Establish a Medical Implant
    Communications Service in the 402-405 MHz Band) ("*MICS Order*"), 14
    FCC Rcd, 21040 (1999).

[^6]: *Id.* at 21042-43.

[^7]: In this band, Metaids currently operates radiosondes, which are
    automatic transmitters, usually carried on an aircraft, free
    balloon, kite, or parachute, which transmit meteorological data
    during their journey through the atmosphere. (See 47 C.F.R. § 2.1.)

[^8]: *Id.* at 21046.

[^9]: 47 C.F.R. § 95.628(c), (d).

[^10]: 47 C.F.R. § 95.1211.

[^11]: 47 C.F.R. § 95.625(a).

[^12]: The Commission also provided that a MICS device could transmit
    without prior frequency monitoring, pursuant to a non-radio
    frequency actuation signal generated by a device external to the
    body (manual activation) (47 C.F.R. § 95.1209(b)), or in response to
    a medical implant event (47 C.F.R. §§ 95.628(b), 95.1209(b)). These
    functions are not the subject of the instant waiver request.

[^13]: NTIA is responsible for managing the Government portion of the
    Table of Frequency Allocations. In bands shared between Federal and
    non-Federal Government services, the Commission and NTIA operate
    under a long-standing coordination agreement. *See Manual of
    Regulations and Procedures for Federal Radio Frequency Management*,
    May 2005 Revision, Sec. 2.4.1.

[^14]: *In re Biotronik, Inc.* (*Philos MO&O*), 18 FCC Rcd. 3027 (2003).
    This decision affirmed on review the earlier action of the Office of
    Engineering and Technology (OET) that found that a regular periodic
    transmission violated the MICS rules.

[^15]: *In re Biotronik, Inc.* (*Biotronik Order*), 19 FCC Rcd. 4208
    (2004). Medtronic opposed the earlier grant of equipment
    authorization and the request for waiver for the Biotronik Philos
    DR-T, on the basis that the periodic operation of the device without
    LBT functionality violates the MICS rules.

[^16]: Public Notice, August 24, 2005, Report No. 2725 (RM-11271).

[^17]: The STS uses a separate injectible probe that must be replaced
    every several days (the transmitter to which it is attached is more
    permanent); the LTS is a more complete monitoring unit that is fully
    implanted and remains for up to one year.

[^18]: *Biotronik Order*, *supra*.

[^19]: See para. 6, *supra*.

[^20]: *See* *WAIT Radio v. FCC*, 459 F.2d 1203, 1207 (D.C. Cir. 1972).

[^21]: *See* 47 C.F.R. § 1.925.

[^22]: *MICS Order*, *supra* at 21040.

[^23]: Type 2 diabetes is the most common form of diabetes, in which
    either the body does not produce enough insulin or the cells ignore
    the insulin. Without insulin, the body is unable to use sugar, which
    is the basic fuel for the cells in the body, and insulin takes the
    sugar from the blood into the cells. When sugar (glucose) builds up
    in the blood instead of going into cells, it can cause two problems:
    cells are immediately starved for energy, and over time, high blood
    glucose levels damage your eyes, kidneys, nerves or heart and lead
    to deterioration of the feet and legs.

[^24]: 47 C.F.R. § 95.639 permits a maximum EIRP of 25 microwatts.

[^25]: We note that FDA will require that patients continue to "finger
    prick," to ensure the availability of blood glucose information in
    the event of a malfunction of the device.

[^26]: Medtronic cites devices that operate under Part 15 of the FCC's
    rules at 315 MHz, 418 MHz, and 916.5 MHz.

[^27]: 47 C.F.R. § 95.1201.

[^28]: See Appendix 1 to Subpart E of Part 95 -- Glossary of Terms.

[^29]: *Biotronik Order, supra* at 4214.

[^30]: We would not, of course, require the removal of LTS devices
    appropriately implanted pursuant to this waiver; we would require
    discontinuation of use of STS devices.