**Before the**

Federal Communications Commission

Washington, D.C. 20554

+----------------------------------+----+------------------------------+
| In the Matter of                 | *  | ET Docket No. 06-135         |
|                                  | *) |                              |
| Investigation of the Spectrum    | ** | RM-11271                     |
| Requirements for Advanced        |    |                              |
| Medical Technologies             | *  | ET Docket No. 05-213         |
|                                  | *) |                              |
| Amendment of Parts 2 and 95 of   | ** | ET Docket No. 03-92          |
| the Commission's Rules to        |    |                              |
| Establish the                    | *  |                              |
|                                  | *) |                              |
| Medical Device Radio             | ** |                              |
| Communications Service           |    |                              |
|                                  | *  |                              |
| at 401-402 and 405-406 MHz       | *) |                              |
|                                  | ** |                              |
| DexCom, Inc. Request for Waiver  |    |                              |
| of the Frequency Monitoring      | *  |                              |
| Requirements of the Medical      | *) |                              |
| Implant Communications Service   | ** |                              |
| Rules                            |    |                              |
|                                  | *  |                              |
| Biotronik, Inc. Request for      | *) |                              |
| Waiver of the Frequency          | ** |                              |
| Monitoring Requirements for the  |    |                              |
| Medical Implant Communications   | *  |                              |
| Service Rules                    | *) |                              |
|                                  | ** |                              |
|                                  |    |                              |
|                                  | *  |                              |
|                                  | *) |                              |
|                                  | ** |                              |
|                                  |    |                              |
|                                  | *  |                              |
|                                  | *) |                              |
|                                  | ** |                              |
|                                  |    |                              |
|                                  | *  |                              |
|                                  | *) |                              |
|                                  | ** |                              |
|                                  |    |                              |
|                                  | *  |                              |
|                                  | *) |                              |
|                                  | ** |                              |
|                                  |    |                              |
|                                  | *  |                              |
|                                  | *) |                              |
|                                  | ** |                              |
|                                  |    |                              |
|                                  | *  |                              |
|                                  | *) |                              |
|                                  | ** |                              |
|                                  |    |                              |
|                                  | *  |                              |
|                                  | *) |                              |
|                                  | ** |                              |
|                                  |    |                              |
|                                  | *  |                              |
|                                  | *) |                              |
|                                  | ** |                              |
|                                  |    |                              |
|                                  | *  |                              |
|                                  | *) |                              |
|                                  | ** |                              |
+----------------------------------+----+------------------------------+

**NOTICE OF PROPOSED RULEMAKING**

**NOTICE OF INQUIRY**

**AND ORDER**

**Adopted: July 13, 2006 Released: July 18, 2006**

**Comment Date: October 31, 2006**

**Reply Comment Date: December 4, 2006**

**By the Commission:** Chairman Martin and Commissioners Copps, Tate and
McDowell issuing separate statements.

Table of Contents

Heading Paragraph \#

I. introduction 1

II\. Background 6

III\. Notice of Proposed Rulemaking 11

IV\. order 35

V. Notice of Inquiry 36

VI\. Interagency CollaBoration, industry education and device immunity
45

VII\. Procedural matters 50

VIII\. Ordering Clauses 57

APPENDIX A - Parties Filing Pleadings in RM-11271

APPENDIX B - Initial Regulatory Flexibility Analysis

# introduction

1.  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.[^1] These devices use wireless technologies for
    increasingly sophisticated and salutary health care applications. It
    is fair to say that quantum leaps in advanced medical technologies
    are revolutionizing treatment for a wide variety of medical
    conditions and, even more fundamentally, creating new health care
    models serving to improve quality of life for all Americans. For
    example, some of the more advanced research anticipates a time when
    implanted or body-worn devices could enable paralyzed individuals to
    control artificial limbs by thought through wireless interfaces
    between brain, nerve and muscle,[^2] or the vision-impaired might
    have some degree of visual ability restored with the help of a
    microchip placed in the back of the eye.[^3] Even today, implanted
    vagus nerve stimulators that send electric pulses to the brain are
    being used to treat severe chronic depression.[^4] Tremors related
    to Parkinson\'s disease are being treated with deep brain
    stimulation implants.[^5] With other new types of implants, such as
    insulin pumps, physicians could wirelessly retrieve data and then
    make operating parameter adjustments with greater ease and accuracy
    than with the more traditional wired connection technologies, and in
    some cases, changes can be effected immediately by computer
    control.[^6] 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.[^7]

2.  The Commission presently has rules in place for wireless medical
    radiocommunication technologies that were based on initial devices
    and their applications. It now appears, however, that the pace and
    nature of development of newer, more capable, and more sophisticated
    devices may be inadequately accommodated by those rules. Some
    current developments and devices are familiar to us, and the nature
    of the rule changes necessary to better provide for them seem
    readily apparent. We are also expectant, however, that there will be
    following generations of devices with which we are not yet
    adequately familiar, and whose needs should be taken into
    consideration to the extent they can be anticipated.

3.  Accordingly, we hereby initiate a two-fold undertaking. We first
    propose certain modifications to our rules to better accommodate new
    medical devices immediately and imminently available. In particular,
    we propose to allocate two megahertz of spectrum for use by
    implanted and body-worn medical radio transmitting devices in the
    401-402 MHz and 405-406 MHz bands that would be governed by rules
    generally similar in nature to those for the existing Medical
    Implant Communication Service (MICS) allocation in the 402-505 MHz
    band, but also would provide for the operation of certain low-power,
    low duty cycle medical devices without listen-before-talk (LBT)
    capability. We also address two current rule waivers that permit the
    operation of low power, low duty cycle medical devices without LBT
    in the existing 402-405 MHz MICS band. We next seek comment on
    whether implanted medical devices that rely upon inductive signal
    coupling should be permitted to operate in the 90-110 kHz band.

4.  We also begin an inquiry into additional developments that are
    anticipated in the medical devices field and their likely spectrum
    requirements that will enable us to subsequently develop proposals
    for additional rules as may be appropriate for their operation,
    based on the input we receive. More specifically, we seek detailed
    comment on new implant and body-worn medical radiocommunication
    technologies and how the Commission could anticipate and proactively
    address the challenging array of RF spectrum sharing issues raised
    by their increasing use, including the protection of user health and
    safety when implants receive interference from primary allocated
    services in the band. We seek comment on the relative benefits and
    tradeoffs that should be considered with respect to both licensed
    and unlicensed approaches to authorizing the operation of these
    devices. Finally, we also seek comment on collaborative efforts
    between this Commission (FCC) and the U.S. Food and Drug
    Administration (FDA) regarding options for better educating device
    manufacturing industry leaders and RF wireless technology leaders
    about medical radio device electromagnetic compatibility (EMC)
    coexistence issues in an RF environment.[^8] Our goal is to create
    an environment that fosters continuing advances in medical devices
    through flexible RF spectrum allocations with the minimum FCC
    regulatory requirements that are necessary for efficient use of the
    spectrum and to ensure patient safety.

5.  Our focus in this proceeding is on implanted and body-worn medical
    radiocommunication devices that serve to actively manage and
    maintain body functions and/or health conditions, and the spectrum
    needs and appropriate operational protocols for such devices.[^9] We
    note that the medical community also uses basic telemetry
    transmission for many other communications purposes, but these uses
    are distinct in their needs and means of accommodation.[^10] We do
    not seek comment here on operations permitted by the wireless
    medical telemetry service (WMTS) under Part 95 of our Rules. Parties
    may comment, however, on whether the concerns and issues raised
    herein are also applicable to any particular medical telemetry
    functions that should be similarly accommodated.

# Background

6.  The Commission has a long history of providing for the reliability
    of communications related to medical care. In 1973, for example, the
    Commission authorized the use of 18 frequencies in the 460-470 MHz
    band on a licensed basis under Part 90 of our rules for low-power
    biomedical telemetry operations in hospitals, other medical
    facilities, and convalescent centers.[^11] As medical telemetry
    increased and its spectrum needs expanded, the Commission, in the
    year 2000, allocated 14 megahertz of 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, for the
    transmission of patient medical information to a central monitoring
    location in a hospital or other medical facility.[^12]

7.  With the development of increasing numbers and kinds of medical
    radio devices, the Commission responded to advances in medical
    implant technology by establishing the Medical Implant Communication
    Service (MICS) within Part 95 of its Rules in 1999.[^13] Therein,
    the Commission set aside three megahertz of spectrum, at 402-405
    MHz, on a licensed-by-rule basis expressly for allowing physicians
    to establish high speed, easy-to-use, short-range wireless links
    between ultra-low power medical implant transmitters and their
    associated programmer/control equipment.[^14] 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. Current examples of such implant devices
    include cardiac pacemakers and defibrillators that also monitor and
    report heart condition.

8.  More recently, the Commission granted petitions for waivers of the
    MICS rules to accommodate new medical radio devices that use
    technology less sophisticated, but no less therapeutic, than
    contemplated when the rules were adopted.[^15] Subsequent to these
    petitions for waiver, Medtronic, Inc. (Medtronic), a manufacturer of
    implantable medical radio devices, filed a petition for rulemaking
    seeking to amend our rules to accommodate additional numbers and
    types of implanted and body-worn medical radio devices, including
    such as those which required rule waivers in order to operate.[^16]
    Several parties filed responsive pleadings. More recently,
    Biotronik, Inc. (Biotronik, see n. 15, *supra*) filed a petition for
    rulemaking that addresses the same issues.[^17]

9.  In addition to these licensed uses, manufacturers of medical radio
    devices (as well as manufacturers of medical telemetry equipment)
    can market products that operate on an unlicensed basis under Part
    15 of our rules. Indeed, from the records on our equipment
    authorization database, we see that the great majority of all
    medical radio devices authorized to date operate on an unlicensed
    basis under Part 15. Among the frequencies used by medical radio
    devices on an unlicensed basis are 9-315 kHz, 13.553-13.556 MHz (13
    MHz ISM band), 174-216 MHz (TV channels 7-13), 218-222 MHz, 293-320
    MHz, 410-450 MHz, 512‑608 MHz (TV channels 14-36), 614-668 MHz (TV
    channels 38-46), 902-928 MHz (915 MHz ISM band), 2400-2483.5 MHz
    (2.45 GHz ISM band), and 5725-5875 MHz (5.8 GHz ISM band).[^18] In
    2002, however, the Commission decided that equipment approval would
    no longer be available for in‑hospital medical telemetry equipment
    operating in the 174-216 MHz and 470-668 MHz bands under the
    provisions of Part 15 or Part 90 (except in the 1427-1432 MHz
    band).[^19] Since that time, approval for new medical telemetry
    equipment must be sought pursuant to the WMTS rules in Part 95.[^20]
    Certain medical devices also operate on an unlicensed basis using
    inductive techniques at low frequencies. However, some inductive
    devices may produce RF energy in restricted frequency bands that
    were established to protect against interference to services that
    are used for safety or low-signal operations.[^21] In that
    connection, Guidant Corporation (Guidant) filed a petition for
    rulemaking to allow unlicensed operation by medical implant devices
    that employ inductively coupled signals for data communication in
    the 90-110 kHz restricted frequency band. Guidant asks that this
    authority be provided by inclusion in the MICS rules by
    specification of this additional band, or by exception to the
    restricted frequency band rule for unlicensed devices.[^22]

10. The suggestions in the Medtronic and Guidant petitions and the
    pleadings filed in response to them, as well as our own experience
    in regulating medical implant devices, comprise the basis for our
    specific proposals, as follows.

# Notice of Proposed Rulemaking

11. *MICS Rules.* The Commission adopted the MICS rules to provide for
    the transmission of operational, diagnostic, and therapeutic
    information associated with a medical implant device.[^23] MICS
    operations, as originally envisioned, include a matched pair of
    devices. The medical implant transmitter is implanted in the body to
    sense body functions and/or conditions and to transmit corresponding
    data; its function is initiated by an external non-radio device or
    by an implant programmer/control transmitter,[^24] which receives
    the data from the implant transmitter and can record or pass on the
    data via interconnection with an external telecommunications
    system.[^25] The technical standards for MICS are designed to ensure
    compatibility among multiple uncoordinated MICS transmitters.[^26]
    Among other requirements, MICS devices are limited to a very low
    maximum EIRP of 25 microwatts in order to avoid potential harmful
    interference to other in-band operations.[^27] The rules require
    that the programmer/control transmitter incorporate a frequency
    monitoring (*viz.*, "listen-before-talk") mechanism to determine
    whether a channel is available for operation.[^28] Furthermore, MICS
    channels are available on a shared basis only, and those using MICS
    transmitters must cooperate in the selection and use of channels in
    order to reduce interference and make the most effective use of
    authorized facilities.[^29]

12. In adopting the MICS rules, the Commission selected the 402-405 MHz
    band for MICS operations due to its signal propagation
    characteristics in the human body, the relative dearth of other
    users of the band, the compatibility of the MICS service with
    incumbent federal government meteorological operations, and the use
    of these frequencies internationally for this purpose.[^30] The
    allocation was made secondary in order to protect incumbent Federal
    Government meteorological operations in the band.[^31]

13. In 2004 and again in 2006, the Commission granted temporary waivers
    for certain medical implant transmitters to operate in the 402-405
    MHz MICS band.[^32] The data transmissions from these devices occur
    on a periodic basis rather than in response to recurring query from
    a programmer/control transmitter or other external device, and they
    each operate on a single channel without the requisite frequency
    monitoring capability. However, they operate with very low power and
    low duty cycles in order to minimize the likelihood that they would
    cause interference. The Commission granted the waivers for limited
    periods of time based on showings by Biotronik and DexCom that the
    devices could not presently be made to comply with the MICS rules,
    but would pose a negligible risk of interference to other medical
    radiocommunication devices or primary users in the MICS band, and
    would provide significant medical benefits for patients.[^33] In
    granting the waivers, the Commission anticipated the need to revisit
    its rules for medical devices, and conditioned those waivers on the
    outcome of such rulemaking.

14. *Medtronic Rulemaking Petition and Responsive Comments*. On July 15,
    2005, Medtronic filed a Petition for Rulemaking (Medtronic petition)
    proposing to establish a new service for implantable and body-worn
    medical radiocommunication devices in two megahertz of spectrum (at
    401-402 MHz and 405-406 MHz) adjacent to the existing MICS 402-405
    MHz band.[^34] Medtronic states that this new allocation would
    complement the existing MICS allocation and support advances in
    medical sensor technology and the expected proliferation of such
    devices, especially those used for lower-cost medical monitoring and
    non-emergency reporting applications.[^35]

15. As requested by Medtronic, this new allocation would provide for a
    "two-tiered" service of ultra-low power radio devices that would
    support short-range data communications from implanted, body-worn,
    and associated external medical devices. The first tier service
    would include implantable devices substantially identical to those
    permitted under the existing MICS rules, as well as body-worn
    medical radiocommunication devices. Devices operating with
    relatively higher power in this first tier would be required to
    employ frequency-monitoring technology. The second tier service
    would permit the operation of devices with very low power and low
    duty cycle that do not employ frequency monitoring, and would
    otherwise be prohibited in the MICS bands. Medtronic asserts that
    this new allocation could, among other benefits, foster the
    development of an array of new medical devices that would improve
    the quality of health care. Medtronic also asserts that this "would
    further encourage worldwide harmonization of a \[medical\] service
    band that the ITU-R has already found to be compatible with
    incumbent uses."[^36]

16. On August 24, 2005, the Commission released a *Public Notice*
    seeking comment on Medtronic's petition.[^37] DePuy Orthopaedics,
    Intel Corporation (Intel), Medtronic, Transoma Medical (Transoma),
    and Zarlink Semiconductor Inc. (Zarlink) submitted comments
    generally supporting the Medtronic Petition, while DexCom and Dr.
    W.G. Scanlon (Scanlon) offer partial support.[^38] Biotronik opposes
    the Medtronic request.[^39] As noted above, on June 16, 2006,
    Biotronik also filed a petition for rulemaking, with proposals that
    conflict with those in the Medtronic petition, which will be
    considered herein.[^40]

17. Intel and others note that the requested new allocation would allow
    for the development of consumer medical sensing devices that could
    be used for monitoring outside of clinical environments.[^41] Intel
    states that there are multiple manufacturers that could readily
    modify their MICS designs to produce compliant products under
    Medtronic\'s two-tiered plan. Transoma and Zarlink state that
    devices permitted by such an allocation would allow physicians to
    determine the status of the patient's condition in real time by
    communicating medical status information.[^42] They argue that this
    would provide for early detection of events that may threaten the
    patient's life or lead to hospitalization and allow physicians to
    adjust internal and external medical radio devices with improved
    efficiency and accuracy.

18. DexCom states that it does not oppose the allocation of additional
    new spectrum for use by medical implant devices on general
    principles. However, both DexCom and Biotronik oppose any plan for
    the 402-405 MHz MICS band that would eventually force any currently
    deployed devices to move to new spectrum and/or to operate with
    reduced power levels.[^43] DexCom also opposes a two-tiered system
    wherein some devices in any particular frequency band would be
    subject to more stringent technical requirements than others.
    Instead, both DexCom and Biotronik generally prefer rule changes
    that would more flexibly accommodate low power, low duty cycle
    devices in the existing MICS band.

19. Finally, Biotronik opposes the creation of a new allocation as
    suggested by Medtronic. Biotronik argues that the record does not
    support Medtronic's proposal. In particular, Biotronik argues that
    the MICS band is not crowded and that, as a result, a variety of
    devices (including low power, low duty cycle devices not having
    frequency monitoring technology) can coexist - particularly where
    the risk of interference is so low.[^44] It argues that the current
    rules limit the utility of the band for some applications due to
    increased complexity and power drain required by compliance.
    Biotronik recommends that, instead of creating a new allocation, the
    Commission consider changes in the present MICS regime in the
    402-405 MHz band to accommodate a wider range of devices, including
    devices that do not meet the current frequency monitoring
    requirements. Biotronik specifically proposes that the rules
    accommodate devices without frequency monitoring and agility if they
    maintain a maximum duty cycle of 0.1% per hour and a maximum power
    level of 100 nW effective radiated power. Furthermore, in its
    rulemaking petition, Biotronik proposes that a specific 300 MHz
    channel be set aside for such devices at 403.65 MHz +/- 150 kHz; and
    notes that this would be consistent with worldwide MICS allocations.
    It also suggests that this channel could be used as a "beacon"
    channel to initiate communication sessions for listen-before-talk
    devices in an efficient manner by avoiding repeated polling by the
    external device. It also argues that its proposal is consistent with
    the direction in which the European Telecommunications Standards
    Institute is moving, referring to a proposal by the ETSI Technical
    Committee Electromagnetic Compatibility and Radio Spectrum Matters,
    Task Group TG30.[^45]

20. *Proposal for Amending MICSs.* As demonstrated by the response to
    the Medtronic petition for rulemaking, there is significant interest
    in using the 401-406 MHz MICS band for new diagnostic, therapeutic,
    and monitoring medical technologies. Based on the information
    provided by all parties, we are proposing to add two additional
    megahertz of spectrum for implanted and body-worn medical
    transmitters to the existing MICS allocation at 402-405 MHz. We
    specifically propose to add the 401-402 MHz and 405-406 MHz ("wing"
    bands) to the existing MICS allocation. In effect, this would make
    the entire 401-406 MHz (MedRadio) band available for both implanted
    and body-worn devices, while preserving the core 402-405 MHz
    (existing MICS) band for devices which, as discussed more fully
    below, have a frequency agility capability. These new "wing" bands
    appear well-suited for implanted and body-worn medical radio devices
    for the same reasons 402-405 MHz was originally designated for MICS,
    *i.e.*, propagation characteristics, availability, and compatibility
    with other users.[^46] We also believe that the provision of
    contiguous spectrum will provide for the maximum efficiency of
    design and operation. We propose to maintain much of the existing
    MICS rules in this spectrum, but not on an exclusive basis, and we
    also propose to continue to license use of MICS devices by rule. We
    further propose to permit non-implanted transmitters, such as those
    that are worn on the body ("body worn"), that are connected to
    implanted devices under these rules. Accordingly, we will henceforth
    refer to this service as "Medical Device Radiocommunication
    Service," ("MedRadio") - rather than MICS - to eliminate the
    implication that it is intended exclusively for implanted radios or
    implanted devices. We seek comment on whether the various current
    MICS rules would continue to be appropriate for operations under the
    new allocation, on the explicit inclusion of non-implanted
    transmitters, and on whether certain medical devices as contemplated
    herein would be better served by a licensed operation regime.

21. We note that Medtronic suggests limiting the maximum authorized
    channel bandwidth for all devices to 100 kHz in the new bands as
    contrasted with the 300 kHz channel bandwidth permitted for the MICS
    center band,[^47] and more stringent emission limits for the wing
    bands than the present MICS limits.[^48] Medtronic also recommends
    that the measured field strength limits for body-worn transmitters
    be reduced by 4 dB to account for the lack of body absorption of
    radiated power that occurs with implanted transmitters.[^49] We seek
    comment on whether there are some functions for which a narrower
    bandwidth is appropriate, and why, and whether there is sufficient
    justification for the more stringent attenuation limits described in
    the Medtronic petition. Commenters supporting emission limits other
    than those currently in the rules should provide technical analysis
    and practical rationale explaining why other limits would be more
    appropriate, and the relative difficulty or cost of compliance
    associated with their proposed limits. Commenters proposing a
    reduced field strength for body-worn transmitters should also
    provide technical analysis supporting their position.

22. . The United States, Canada, France, and the Russian Federation are
    active participants in the development of the international Search
    and Rescue Satellite (COSPAS-SARSAT) system. The system is made up
    of SARSAT and COSPAS satellites, terrestrial emergency transmitters,
    local ground stations, mission control centers (MCC) and rescue
    coordination centers (RCC). The COSPAS-SARSAT system determines the
    position of a distressed aircraft, ship, or other vehicle from the
    low-powered emission of an automatic distress beacon. The
    COSPAS-SARSAT system is composed of three main subsystems, the
    distress beacon, the satellite repeater/processor, and the ground
    receiver processor. The low-powered distress signal is transmitted
    by the Emergency Locator Transmitter (ELT) or the maritime
    equivalent Emergency Position Indicating Radio Beacon (EPIRB). The
    signal is detected by the receiver on the spacecraft and data is
    transmitted back to a Local User Terminal (LUT) on the ground, where
    the appropriate MCC and/or RCC is alerted. The processed data system
    is available only for the 406.025 MHz ELT/EPIRB signals. These
    signals contain data as to the type of platform, country of origin,
    identification of ship or aircraft, and type of emergency. The
    signals are recovered, detected and identified by processing on the
    spacecraft. The 406.025 MHz emergency frequency has been designated
    internationally for distress use only. The international
    COSPAS-SARSAT Program announced that it will terminate satellite
    processing of distress signals from 121.5 MHz and 243 MHz EPIRBs and
    ELTs as of February 1, 2009. The implication of this decision is
    that users of EPIRBs and ELTs that send distress alerts on 121.5 MHz
    and 243 MHz should begin using EPIRBs and ELTs operating on 406.025
    MHz if the alerts are to be detected and relayed via satellites.
    Mariners, aviators, and other persons will have to switch to EPIRBs
    and ELTs that operate on 406.025 MHz. Given the importance of this
    frequency to public safety around the world, it must be adequately
    protected. Accordingly, we seek comment on what out-of-band emission
    level in the 406-406.1 MHz band is necessary to protect
    COSPAS-SARSAT satellite receivers.

23. We also propose to adopt rules for the 401-402 MHz and 405-406 MHz
    bands that would permit body-worn and implant transmitters having
    low-power and low duty cycles to operate without frequency
    monitoring capability as suggested by Medtronic and supported by
    several commenters. Because such devices would pose a small risk of
    causing harmful interference, we believe that permitting the
    operation of such devices without frequency monitoring could
    simplify device designs, reduce their size, and extend their
    operational life. This could help lower the cost of medical data
    collection and therapy in both the care center and home
    environments, as well as provide physicians with an easy and
    accurate way to make routine adjustments to internal and external
    medical radio devices such as neural stimulators and insulin pumps.
    We further believe that providing additional spectrum for deployment
    of these devices could prove beneficial in keeping otherwise healthy
    individuals out of hospital beds and nursing facilities and allow
    many more individuals to live independently for a longer period of
    time. We seek comment on the potential benefits of expanding the
    authority for operation of 400 MHz medical devices that do not
    employ LBT frequency monitoring capabilities.

24. We believe that allowing devices that do not employ frequency
    monitoring in the 401-402 MHz and 405-406 MHz bands, as argued by
    Medtronic and others, would preserve a block of spectrum at 402-405
    MHz for the more critical devices and any others that employ
    frequency monitoring both to protect their function and to reduce
    the risk that they would be subject to interference. This could
    become increasingly important as spectrum use intensifies, for
    critical devices to avoid becoming more susceptible to harmful
    interference from other non-implanted devices and those that
    transmit without prior frequency monitoring. Furthermore, the MICS
    device industry itself is still in its nascent stages and, absent
    compelling reasons, we would be reluctant to upset the existing MICS
    rules for operation in the 402-405 MHz band in light of research and
    development that has taken place in reliance on our rules, and the
    products that are and will soon be available to the public as a
    result. In this light, we are not proposing the modifications to the
    MICS rules suggested by Biotronik in its rulemaking petition that
    suggest permanently allowing the use of certain devices without
    frequency agility within the 402-405 MHz band or setting aside one
    300 kHz channel in that band for such use. However, in order to
    foster a full exploration of options for the entire 401-406 MHz
    band, we invite comment on the potential benefits or disadvantages
    of Biotronik's proposals.

25. Specifically, we propose to allow medical implant or body-worn
    devices and associated control station devices that operate without
    frequency monitoring to operate at 401-402 MHz and 405-406 MHz, and
    to limit such devices to an EIRP that does not exceed 250 nanowatts
    (nW) and a duty cycle that does not exceed 0.1% during any one-hour
    interval. Based on the information available to us, this proposal
    appears to reflect a reasonable balance between the operational
    capabilities needed for devices to function properly and the need to
    minimize the risk of interference to other devices in the band.[^50]
    We seek comment on this proposal, including whether other power and
    duty cycle thresholds would be more appropriate, and what trade-offs
    they would entail.

26. We also note Biotronik's contention that there is ample capacity in
    the current MICS allocation for a variety and large number of
    devices, and seek additional comment on whether the additional
    spectrum we propose is needed for future medical devices, or whether
    such devices should be accommodated in the existing 402-405 MHz
    allocations, with appropriate modifications to the operational
    rules, such as those proposed by Biotronik in its rulemaking
    petition. We also invite comment on whether the 401-406 MHz band
    should be apportioned differently among the various types of
    operation than as proposed above, both in relative amounts of
    spectrum designated, and in the specific frequencies permitted for
    each type of operation. For instance, should a portion of spectrum
    be exclusively designated for non-frequency-monitoring devices, and
    if so, how much? Can the provision of exclusive spectrum for
    frequency monitoring devices be made unnecessary by appropriate
    restrictions on other devices? Is additional spectrum beyond that
    proposed above needed for implanted and body-worn medical radio
    devices? Comments suggesting the allocation of additional spectrum
    should discuss the basis for projecting future types of uses and
    needs.

27. It is apparent from the devices we have examined, as well as the
    comments submitted, that our rules need to be clear as to the
    significance, if any, of the location of the transmitter (in
    particular, the antenna) associated with the medical device. While
    our present MICS rules can be read to have assumed that an implant
    transmitter would be part of a fully implanted device, it is now
    apparent that the transmitter and/or antenna portion of implanted
    devices can, in many cases, be located on (or just below) the
    surface of the skin.[^51] Additionally, it appears that there are
    body-worn devices that can perform critical diagnostic, therapeutic,
    and monitoring functions, and we propose to accommodate such devices
    in our rules. In either case, it is the location of the antenna that
    determines a device's communication capability and its interference
    potential; and, thus its location should dictate the operational
    parameters set forth in the rules. Accordingly, we propose to modify
    our rules to clarify that the transmitter/antenna portion of a
    MedRadio device need not be implanted, but may also be body-worn
    (including placement on, or subcutaneously injected just below, the
    skin). We also seek comment on whether and what different rules or
    frequency bands should be applied to body-worn and implanted
    antennae. We also seek comment on Medtronic's proposed definition of
    a body-worn transmitter as one "intended to be placed on or in very
    close proximity (six centimeters or less) to the human body used to
    facilitate communications from a medical body-worn or implanted
    device.[^52]

28. We note that Medtronic requests that we also amend Section 95.603(f)
    of the rules in order to provide manufacturers with an alternative
    means of demonstrating compliance with the Commission's RF safety
    exposure limits for their medical implant devices.[^53] We do not
    discuss this issue herein because we believe that it is more
    appropriate to address it in the context of our ongoing RF safety
    proceeding (ET Docket No. 03-137) that anticipates dealing with
    proposed changes in the Commission's Rules regarding human exposure
    to RF electromagnetic fields in a more comprehensive fashion.[^54]

29. The rules we propose herein focus on providing the flexibility in
    the use of spectrum for implanted and body-worn medical radio
    devices. We note that the Medtronic petition suggests distinctions
    depending upon factors such as whether a device uses spectrum
    intensively or is used for life-critical applications. We believe
    that it is neither the role, nor the area of expertise, of the
    Commission to adopt rules that would define operating criteria based
    upon such determinations. Instead, we believe that medical device
    manufacturers should be cognizant of the potential health and safety
    risks that could arise if implanted or body-worn medical
    radiocommunication devices are subjected to various levels of RF
    interference in a dynamic and unpredictable RF environment, and
    design their products with appropriate safeguards and robustness as
    is appropriate to their function. We further believe that such
    concerns are more appropriately taken into consideration and
    evaluated as part of the FDA medical device approval process.
    Therefore, we decline to propose any rules based upon such criteria.
    We seek comment on this position.

30. Our intention in proposing these rules is to provide for more
    efficient and intensive spectrum use in the near term by advanced
    medical technologies that feature implantable and body-worn
    transmitters. Our deliberations will be informed by the current
    activity, development, and knowledge in this area. We particularly
    seek information regarding the development of such devices, their
    stage of development, their function, and their spectrum
    requirements and reliability needs. We will also take into
    consideration, to the extent practical, information provided in
    response to our Inquiry, as indicated below, regarding anticipated
    future developments in implanted and body-worn medical devices that
    may rely, in varying degrees, on radiocommunication for their
    functionality.

31. *Inductive Telemetry.* Guidant Corporation manufactures medical
    devices for cardiac patients, including implantable pacemakers,
    implantable cardioverter defibrillators (ICDs) and cardiac
    resynchronization therapy (CRT) devices that use inductive coupling
    to communicate heart information between patients and doctors.
    Inductive medical devices must be coupled to external programmers or
    readers by means of low level magnetic pulses.[^55] Magnetic
    coupling requires very close spacing between the implanted device in
    the patient and external monitoring/control equipment, often
    requiring body contact for proper operation.[^56] The inductive
    magnetic pulses generated by these inductive devices also produce RF
    energy. The Guidant devices produce RF energy in the 90-110 KHz band
    as a consequence of its inductive coupling technique.

32. Part 15 of our rules restricts radiation from unlicensed devices in
    certain frequency bands (\"restricted bands\") to spurious emissions
    only.[^57] The 90-110 kHz band is included among the restricted
    bands in order to protect incumbent the Loran-C operations.[^58]

33. Guidant states that it is unclear how induction devices fit under
    the Commission's restricted band prohibition of Section 15.205.[^59]
    While acknowledging that its devices produce RF energy in the 90-110
    KHz band, Guidant also argues that these emissions could be
    considered spurious under our rules.[^60] In that regard, Guidant
    argues that its devices rely upon the magnetic pulses rather than
    the RF energy produced in order to function. Furthermore, Guidant
    argues that since the RF energy produced by its devices could be
    suppressed without affecting its inductive communications ability,
    the RF component could nevertheless be deemed a spurious
    emission.[^61] Guidant also states the emission levels from its
    devices are so low that there is little risk of interference being
    caused to any other devices or services in the band. Accordingly,
    Guidant asks the Commission to amend the Part 95 Rules to include
    medical implant devices such as those made by Guidant that use
    inductive telemetry in the 90-110 kHz band. More specifically, it
    requests that the Commission provide a narrow exception to the Part
    15 restricted band prohibitions for medical implants or, preferably,
    amend the MICS rules to expressly include all implants, including
    those that operate inductively in the 90-110 kHz band. Guidant urges
    that making a provision in the rules for these devices would be
    beneficial because the alternative of being required to modify its
    devices to suppress the RF energy would only result in added device
    cost and complexity with no discernable interference reduction
    benefit.

34. We seek comment on whether inductive devices such as those made by
    Guidant should be authorized to operate if they produce RF energy in
    the 90-110 kHz band. We ask commenters to address the advantages and
    disadvantages of allowing or prohibiting such operation, including
    the resulting interference potential. If such operation were to be
    permitted, what approach should be taken? For example, similar to
    the modified MedRadio rules proposed herein, a secondary allocation
    for inductively coupled medical devices could be created in the
    90-110 kHz band on a licensed-by-rule basis under Part 95. Another
    option would be to provide an exception to the restricted band
    spurious emission limits for unlicensed medical devices that use
    inductive coupling in the 90-110 kHz band. Alternatively, a waiver
    could be granted that would permit manufacture, sale, and use of
    such devices for a limited period of time until devices fully
    compliant with the present rules can be developed. We invite
    commenters to address the relative merits these options, and to
    suggest any other options.[^62] We also seek comment on the more
    general question raised by Guidant concerning how to address
    emissions from medical implant devices that employ inductive
    coupling technology for communicating with associated external
    devices.

# ORDER

35. As previously noted, two families of noncompliant devices are
    currently authorized for use in the MICS band.[^63] The DexCom
    waiver is effective until January 19, 2009 (or until one year after
    the completion of any rulemaking the Commission may undertake,
    whichever is later). In granting the DexCom waiver, the Commission
    anticipated both the need to undertake the instant rulemaking, as
    well as further developments in medical technology. The Biotronik
    waiver is effective until February 26, 2007. In light of the need
    for physicians and patients to reasonably anticipate the
    availability of such critical products, Biotronik has already filed
    a request for extension of its waiver.[^64] Given the importance of
    these devices and the fact that we have thus far found no instances
    of interference involving their use, we hereby grant Biotronik's
    request for extension of its waiver, pending adoption of new
    MedRadio rules as proposed today. To the extent the Biotronik device
    is not compliant with the forthcoming rules, we will require that
    Biotronik modify its device to ensure compliance within one year of
    the effective date of such rules. Our intent is to render consistent
    the Biotronik waiver with that granted to DexCom (which, as noted
    earlier, provides one year beyond completion of the instant
    rulemaking), as well as to ensure adequate transition time for
    modification of the subject devices as may be necessary. We will,
    however, also retain the option to permit the continued manufacture
    and use of either the DexCom or Biotronik devices for an additional
    period, or indefinitely, depending on considerations such as the
    availability of technology and parts for compliant equipment at the
    time we adopt our new MedRadio rules. Finally, we note that parties
    may comment on the propriety of further extending the Biotronik and
    DexCom waivers beyond the extension provided herein.

# Notice of Inquiry

36. As noted in the Introduction, above, it appears that the health care
    industry has reached the beginning of a wave of breakthroughs in
    providing care and rehabilitation that will use radiocommunication
    technologies in a variety of ways. There is already development in
    such medical devices to assist in everything from motor function to
    eyesight, significantly mitigating the effects of once debilitating
    injuries or diseases. For instance, we understand that at least one
    research organization, the Alfred E. Mann Foundation, is working on
    RF-powered microstimulators for nerves and muscles and other
    applications.[^65] More and more sophisticated devices are also
    being developed to monitor various health conditions and to control
    the medication for a wide variety of ailments and diseases, leading
    to better management of these conditions to reduce their morbidity,
    their effects on overall health, and patients' quality of life and
    life expectancy. We must also be aware of medical devices that do
    not directly utilize radio communication, but can affect or be
    affected by the RF environment. As one example, researchers at the
    Massachusetts Institute of Technology (MIT), Vivo Metrics, and other
    research centers are developing a vest (and other clothing articles)
    with a surface that is completely electrically conductive, so that a
    variety of sensors can be placed at locations as appropriate for
    individual patients and wirelessly feed medical information back to
    a data collection point on the vest.[^66] Thus, we seek information
    on evolving trends in medical radio device development to determine
    the long-term adequacy of the Medical Device Radiocommunication
    Service rules proposed herein and, if so guided by the comments and
    information received in response to this Inquiry, to propose
    additional rules and/or additional spectrum for the operation of
    such devices. Because increasing numbers of implanted and body-worn
    medical devices rely upon wireless radiocommunication technologies,
    we seek to develop a comprehensive record concerning the present and
    future RF spectrum requirements as well as device immunity issues
    with respect to these medical radio devices in order to better
    inform our current rulemaking effort and to provide a basis for
    further rule changes.

37. In order to gain a more informed perspective on the evolving
    spectrum needs for implanted and body-worn medical radio devices
    that will use spectrum, or other devices that will affect or be
    affected by MedRadio devices, we seek information on existing
    devices as well as those that might be outside the scope of the
    rules proposed above. Commenters should include any available
    information on the developmental status and anticipated market
    deployment timelines for planned and envisioned future devices. From
    the manufacturing and deployment perspective, we seek comment on the
    extent to which existing and planned devices have spectrum operating
    needs different from each other and different from those that will
    be accommodated by the rules adopted in response to the proposals
    above, and what those needs might be. For example, we invite
    commenters to address whether some frequency bands are preferable
    for use due to physiological characteristics with respect to RF
    propagation through body tissue. Would it be beneficial to separate
    certain types of implanted and body-worn medical radio devices into
    specific operating frequency bands where they would be less likely
    to be interfered with by other types of medical radio devices? We
    ask whether any of the newer devices will require exclusive spectrum
    or can share spectrum with existing users. We seek input about the
    nature and function of the devices, particularly if such devices
    incorporate life supporting or critical functions, and their
    potential susceptibility to RF interference from other medical and
    non-medical RF emitters. What techniques will, or can, such devices
    employ to ensure an adequate level of robustness and with what types
    of other operations can they feasibly share spectrum? What power
    levels and duty-cycles will these new devices require? Could
    additional changes in the rules governing the frequency bands
    already allocated for medical radio devices prove beneficial? If so,
    what would be the impact of such changes, positive or negative, on
    existing services in the band?

38. With respect to spectrum management, we seek comment on whether
    there are ways in which we could anticipate, and proactively avoid,
    RF interference between various medical radio devices, as well as
    with non-medical devices sharing the same spectrum, before they
    occur. Could different rules than those proposed above eventually
    provide greater flexibility to encourage technological advancement
    while fostering more intensive spectrum use and, if so, how? If
    additional spectrum will be needed for new devices, what spectrum is
    suitable and available?

39. The Commission's rules in some instances specify the emission type
    or modulation schemes that are permitted in particular frequency
    bands;[^67] for example, a MICS station may transmit any emission
    type appropriate for communications in that service, except that
    voice communications are prohibited.[^68] Should all emission types
    be permitted within any particular band, or should some restrictions
    be imposed to address interference concerns, channelization,
    spectrum efficiency or related concerns? What criteria should be
    used for identifying emission types that would either be permitted
    or prohibited? What types of devices should be allowed to operate in
    the spectrum identified for medical radio use? Should any
    restrictions be placed on the locations in which these devices
    should operate? Should some form of spectrum-sharing etiquette be
    considered in certain frequency bands? Would it be beneficial if a
    medical radio device were permitted to use its primary operating
    frequency to enable networked communications with other devices or
    systems in the same frequency band? How could such use best be
    accomplished, and what would be the tradeoffs in terms of spectrum
    sharing and possibly increased RF congestion? Parties may also wish
    to comment on any other related issues or approaches not mentioned
    herein so that we may develop the most comprehensive record
    possible.

40. We also recognize that international harmonization of the operating
    frequencies for medical radio devices could be beneficial. This
    could foster a more expeditious deployment of medical radio devices
    using the same basic device designs over wider international markets
    and at reduced costs. In addition, persons with implanted or
    body-worn medical radio devices would be able to travel
    internationally with greater confidence that their medical radio
    devices would continue to operate properly and have greater
    compatibility with device support infrastructure in other countries.
    Thus, we seek comment on how domestic RF allocations could or should
    be better harmonized with international RF allocations.

41. We seek comment on any medical device manufacturing industry
    standards work that has been done domestically or internationally on
    medical radio devices, and the results of such activities. We are
    interested in evaluating how important standardization will be for
    all or certain medical radio devices, both for manufacturing ease
    and/or economy and for patient safety and medical device
    effectiveness when traveling. We are also interested in the cost or
    difficulty in achieving such standardization in any respects. Among
    other matters, commenters should address what, if any, international
    standards should be investigated for possible consideration in the
    United States to facilitate the development of medical radio devices
    for a global marketplace. What aspects of these international
    standards might prove to be beneficial domestically? Why would they
    be beneficial? What are the disadvantages? What steps should the
    Commission take to encourage this work? Are there other standards
    bodies involved in similar activities?

42. As explained above, under our current rules a wide range of
    frequencies between 9 kHz and 2483.5 MHz may be used under our
    current rules by medical devices - some on a licensed, and others on
    an unlicensed basis. As a general condition of operation, Part 15
    devices may not cause harmful interference to authorized radio
    services and must accept any interference that they receive.[^69]
    Consequently, medical devices operating under Part 15 may be more
    likely to experience harmful interference, particularly from other
    authorized non-medical devices sharing the same RF spectrum.

43. We note that this is not the first time we have addressed these
    concerns. For example, as previously noted, the Commission
    established the WMTS in response to a reported case of interference
    to unlicensed biomedical telemetry operations under Part 15 on a
    previously vacant TV channel that occurred when a new digital
    television (DTV) station began test transmissions on the same
    channel.[^70] The Commission also sought to address the potential
    for harmful interference to biomedical telemetry devices from
    co-frequency, high power private land mobile radio (PLMR) operations
    in the 460-470 MHz band.[^71] In 2002, the Commission decided that
    equipment approval would no longer be available for in‑hospital
    medical telemetry equipment operating in the 174-216 MHz and 470-668
    MHz bands under the provisions of Part 15 or Part 90 (except in the
    1427-1432 MHz band).[^72] Since that time, approval for new medical
    telemetry equipment must be sought pursuant to the WMTS rules in
    Part 95.[^73]

44. Accordingly, we seek comment on the relative merits of licensed
    versus unlicensed approaches for authorization of new types of
    medical radio devices, especially with regard to addressing the
    potential for harmful interference to such devices. Are there
    situations, such as life-critical applications, where a licensed
    approach would be more beneficial? If so, how would
    \"life-critical\" be defined or a "life-critical" threshold
    determination be made, and by whom? Would certain wireless
    networking technologies, such as Wi-Fi, or others provide a more
    flexible and readily deployable infrastructure to support medical
    radio devices if utilized for medical purposes on an unlicensed
    basis? Should the operation of medical radio devices under Part 15
    for medical applications on frequencies that are shared with other
    non-medical devices or services be discouraged or prohibited? If so,
    what measures would be appropriate? How would such alternative
    approaches be implemented and managed by regulators and industry? We
    also ask, in a similar fashion to the approach adopted by the
    Commission for unlicensed personal communications service (UPCS)
    devices, whether defining or restricting certain frequency bands
    exclusively for operation of certain type of medical radio devices
    on either an unlicensed or licensed-by-rule basis could address
    these needs.[^74] What would be the benefits and disadvantages of
    such an approach? Are there any other regulatory approaches,
    including hybrids between licensed and unlicensed devices that
    should be considered?

# INTERAGENCY COLLABORATION, INDUSTRY EDUCATION, AND DEVICE IMMUNITY

45. Implantable and body-worn devices will occasionally be brought into
    unpredictable electromagnetic environments, both within and beyond
    the health care setting. In such settings, a medical device could be
    adversely affected if the environmental RF exposure exceeds its EMC
    immunity design and test level, or if effects of RF interference
    cannot be efficiently mitigated.[^75] For example, even while
    confined inside a health care facility, the proper operation of a
    medical device may be impaired when brought into proximity to other
    medical equipment such as magnetic resonance imaging (MRI),
    diathermy, or X-ray equipment. In addition, many patients with
    implanted or body-worn medical radio devices could also congregate
    in a health care facility, resulting in a particularly high local
    density of use. In the outside world, concerns may arise when
    implanted medical devices are in close proximity to microwave ovens
    and other electronic equipment that may be either intentional or
    unintentional radiators of RF energy.

46. This Commission and the FDA presently work together concerning
    various aspects of the medical radio devices issues discussed in
    this Inquiry. The Commission's primary efforts focus on promulgating
    regulations that allocate RF spectrum for their particular use, and
    that set operational limits on the RF emissions they generate to
    achieve efficient and effective utilization of the spectrum. The FDA
    addresses device safety and effectiveness, including EMC issues, as
    part of its regulation of medical devices.[^76] Furthermore,
    officials of both agencies periodically meet to discuss matters of
    concern related to the spectrum use and immunity issues discussed
    here. Thus, this Commission and the FDA play individual and
    complementary roles in the authorization and regulation of medical
    radio devices.

47. We seek comment, especially from parties with experience before both
    agencies, on how the two agencies might enhance their collaborative
    efforts toward better educating medical radio devices manufacturers
    and industry alike about RF interference and device EMC issues. How
    can the FCC better meet the challenge and work with the FDA to keep
    pace with evolving technologies? To what extent should such efforts
    be directed toward planning pre-deployment device design
    requirements versus resolving issues that arise after a device is
    developed or even deployed? For example, would it be beneficial to
    provide an FCC web site on which manufacturers or the general public
    could find informational documents on RF allocation and immunity
    issues, or where problems of interference between medical radio
    devices and other radiocommunication devices could be reported?[^77]

48. Should other approaches be explored in cooperation with regulatory
    agencies and manufacturing trade groups to raise the awareness of
    manufacturers and applicants of what is expected (both in submission
    materials and other technical criteria) by the regulatory agencies
    in their respective approval processes concerning electromagnetic
    compatibility (EMC) and electromagnetic interference (EMI),
    including RF interference (RFI)? Should the Commission\'s medical
    radio device rules cross-reference related FDA rules? We also seek
    comment on whether manufacturers are generally aware that they must
    get approval from the FCC, and in most cases the FDA as well, before
    distributing or selling medical radio devices. If not, what method
    of knowledge sharing should be used to distribute this information
    throughout the medical industry? We seek input on any change in FCC
    procedures that might be useful to the industry in this regard. We
    intend to coordinate the comments and suggestions responsive to this
    NOI with FDA as part of our continuing efforts in this area.

49. Finally, we seek comment and suggestions for approaches to
    addressing any other related issues not specifically discussed
    above. Commenters should provide detailed descriptions of such
    issues, including a detailed discussion of the potential benefits
    and difficulties associated with any suggested approach for
    addressing them.

# Procedural matters

50. *Initial Regulatory Flexibility Analysis for the Notice of Proposed
    Rule Making.* As required by Section 603 of the Regulatory
    Flexibility Act, 5 U.S.C. § 603, the Commission has prepared an
    Initial Regulatory Flexibility Analysis (IRFA) of the possible
    significant economic impact on small entities of the proposals
    suggested in this document. The IRFA is set forth in Appendix B.

51. *Initial Paperwork Reduction Analysis.* The *Notice of Proposed Rule
    Making* and *Order* contain proposed new or modified information
    collection requirements. The Commission, as part of its continuing
    effort to reduce paperwork burdens, invites the general public and
    the Office of Management and Budget (OMB) to comment on the
    information collection requirements contained in this document, as
    required by the Paperwork Reduction Act of 1995, Public Law 104-13.
    Public and agency comments are due 60 days after the date of
    publication in the Federal Register. Comments should address: (a)
    whether the proposed collection of information is necessary for the
    proper performance of the functions of the Commission, including
    whether the information shall have practical utility; (b) the
    accuracy of the Commission's burden estimates; (c) ways to enhance
    the quality, utility, and clarity of the information collected;
    and (d) ways to minimize the burden of the collection of information
    on the respondents, including the use of automated collection
    techniques or other forms of information technology. In addition,
    pursuant to the Small Business Paperwork Relief Act of 2002,[^78] we
    seek specific comment on how we might "further reduce the
    information collection burden for small business concerns with fewer
    than 25 employees."

52. In addition to filing comments with the Secretary, a copy of any
    comments on the information collections contained herein should be
    submitted to Judith Boley Herman, Federal Communications Commission,
    445 12^th^ Street, S.W., Room 1-C804, Washington, D.C. 20554, or via
    the Internet to \<Judith-B.Herman@fcc.gov\>, and to Kristy LaLonde,
    Policy Analyst, Office of Information and Regulatory Affairs (OIRA),
    Office of Management and Budget (OMB), Docket Library, Room 10234,
    New Executive Office Building (NEOB), 725 17^th^ Street, N.W.,
    Washington, D.C. 20503, or via the Internet at
    \<LaLonde@omb.eop.gov\>.

53. *Comments.* Pursuant to Sections 1.415 and 1.419 of the Commission's
    rules, 47 C.F.R. §§ 1.415, 1.419, interested parties may file
    comments on or before October 31, 2006, and reply comments on or
    before December 4, 2006. Comments may be filed using the
    Commission's Electronic Comment Filing System (ECFS) or by filing
    paper copies. *See Electronic Filing of Documents in Rulemaking
    Proceedings*, 63 Fed. Reg. 24121 (1998).

54. Comments filed through the ECFS can be sent as an electronic file
    via the Internet to http://www.fcc.gov/e-file/ecfs.html. Generally,
    only one copy of an electronic submission must be filed. If multiple
    docket or rulemaking numbers appear in the caption of this
    proceeding, however, commenters must transmit one electronic copy of
    the comments to each docket or rulemaking number referenced in the
    caption. In completing the transmittal screen, commenters should
    include their full name, U.S. Postal Service mailing address, and
    the applicable docket or rulemaking number. Parties may also submit
    an electronic comment by Internet e-mail. To get filing instructions
    for e-mail comments, commenters should send an e-mail to
    ecfs@fcc.gov, and should include the following words in the body of
    the message, "get form \<your e-mail address\>." A sample form and
    directions will be sent in reply. Parties who choose to file by
    paper must file an original and four copies of each filing. If more
    than one docket or rulemaking number appears in the caption of this
    proceeding, commenters must submit two additional copies for each
    additional docket or rulemaking number.

55. All filings must be addressed to the Commission's Secretary, Office
    of the Secretary, Federal Communications Commission. Filings can be
    sent by hand or messenger delivery, by commercial overnight courier,
    or by first-class or overnight U.S. Postal Service mail (although we
    continue to experience delays in receiving U.S. Postal Service
    mail). The Commission's contractor, Natek, Inc., will receive
    hand-delivered or messenger-delivered paper filings for the
    Commission's Secretary at 236 Massachusetts Avenue, NE., Suite 110,
    Washington, DC 20002. The filing hours at this location 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 mail, Express mail, and Priority Mail should be
    addressed to 445 12^th^ Street, SW., Washington, DC 20554.

56. *Further Information.* For further information, contact Bruce
    Romano, Office of Engineering and Technology, at (202) 418-2124, or
    via the Internet at <bruce.romano@fcc.gov>; or Gary Thayer, Office
    of Engineering and Technology, at (202) 418-2290, or via the
    Internet at <gary.thayer@fcc.gov>.

# Ordering Clauses

57. IT IS ORDERED that pursuant to Sections 1, 4(i), 7(a), 301, 303(f),
    303(g), 303(r), 307(e) and 332 of the Communications Act of 1934, as
    amended, 47 U.S.C. Sections 151, 154(i), 157(a), 301, 303(f),
    303(g), 303(r), 307(e), and 332, this *Notice of Proposed Rule
    Making, Notice of Inquiry, and Order* IS ADOPTED.

58. IT IS FURTHER ORDERED that the Biotronik *Request for Extension of
    Waiver*, referenced above, is granted until one year from the
    effective date of final rules adopted in this proceeding.

59. IT IS FURTHER ORDERED that the Commission's Consumer and
    Governmental Affairs Bureau, Reference Information Center, SHALL
    SEND a copy of this *Notice of Inquiry, Notice of Proposed Rule
    Making, and Order*, including the Initial Regulatory Flexibility
    Analysis to the Chief Counsel for Advocacy of the Small Business
    Administration.

    FEDERAL COMMUNICATIONS COMMISSION

    Marlene H. Dortch

    Secretary

# APPENDIX A {#appendix-a .unnumbered}

# Parties Filing Pleadings in RM-11271 {#parties-filing-pleadings-in-rm-11271 .unnumbered}

[Comments]{.underline}:

1\. Biotronik, Inc. (Biotronik)

2\. (DePuy): late-filed (September 26, 2005)

3\. DexCom, Inc. (DexCom)

4\. Medtronic, Inc. (Medtronic)

5\. Scanlon, Dr. W. G. (Scanlon): late-filed (September 29, 2005)

6\. Transoma Medical: late-filed (September 27, 2005)

7\. Zarlink Semiconductor Inc. (Zarlink)

[Reply Comments]{.underline}:

1\. Biotronik

2\. DexCom

3\. Intel Corporation (Intel)

4\. Medtronic

# APPENDIX B {#appendix-b .unnumbered}

# Initial Regulatory Flexibility Analysis {#initial-regulatory-flexibility-analysis .unnumbered}

As required by the Regulatory Flexibility Act of 1980, as amended
(RFA),[^79] the Commission has prepared this present Initial Regulatory
Flexibility Analysis (IRFA) of the possible significant economic impact
on a substantial number of small entities by the policies and rules
proposed in this *Notice of Proposed Rule Making* (*NPRM*). Written
public comments are requested on this IRFA. Comments must be identified
as responses to the IRFA and must be filed by the deadlines for comments
provided in paragraph **XX** of this *NPRM*. The Commission will send a
copy of this *NPRM*, including this IRFA, to the Chief Counsel for
Advocacy of the Small Business Administration (SBA).[^80] In addition,
the *NPRM* and IRFA (or summaries thereof) will be published in the
Federal Register.[^81]

**A. Need for, and Objectives of, the Proposed Rules**

In this proceeding, the Commission explores future spectrum requirements
for advanced medical devices that use wireless radiocommunication
technologies. Wireless technologies are increasingly being used in
medical devices for a variety of purposes ranging from basic telemetry
transmission to more sophisticated health care applications.[^82] Our
focus in this proceeding is primarily on implanted and body-worn medical
radiocommunication devices (MRDs) that serve to actively manage and
maintain body function/health conditions.[^83] Technological advances in
this field are revolutionizing health care for the benefit of all
Americans. Our goal is to create an environment that fosters continuing
advances through flexible RF spectrum allocations and reduced regulatory
requirements.

Based on the responses we have received to a Petition for Rulemaking
from Medtronic, Inc., we believe that there is need for additional
spectrum in the 400 MHz range for implanted and body-worn MRDs. Thus, in
the Rulemaking portion of this proceeding, we propose to allocate two
megahertz of spectrum for use by MRDs in the 401-402 MHz and 405-406 MHz
bands that are adjacent to the existing Medical Implant Communication
Service (MICS) allocation in the 402-505 MHz band. We seek comment on
establishing a new Medical Data Service (MEDS) that would encompass all
MRDs operating in the entire 401-406 MHz band

**B. Legal Basis**

The proposed action is authorized under 1, 4(i), 7(a), 301, 303(f),
303(g), 303(r), 307(e) and 332 of the Communications Act of 1934, as
amended, 47 U.S.C. Sections 151, 154(i), 157(a), 301, 303(f), 303(g),
303(r), 307(e), and 332.

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

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 proposed rules, if adopted.[^84] The RFA generally
defines the term \"small entity\" as having the same meaning as the
terms \"small business,\" \"small organization,\" and \"small
governmental jurisdiction.\"[^85] In addition, the term \"small
business\" has the same meaning as the term \"small business concern\"
under the Small Business Act.[^86] 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.[^87]

Nationwide, there are a total of approximately 22.4 million small
businesses, according to SBA data.[^88] A "small organization" is
generally "any not-for-profit enterprise which is independently owned
and operated and is not dominant in its field."[^89] Nationwide, as of
2002, there were approximately 1.6 million small organizations.[^90] The
term "small governmental jurisdiction" is defined generally as
"governments of cities, towns, townships, villages, school districts, or
special districts, with a population of less than fifty thousand."[^91]
Census Bureau data for 2002 indicate that there were 87,525 local
governmental jurisdictions in the United States.[^92] We estimate that,
of this total, 84,377 entities were "small governmental
jurisdictions."[^93] Thus, we estimate that most governmental
jurisdictions are small.

**Personal Radio Services**. We are proposing to place the MEDS within
Part 95 of our rules ("Personal Radio Services"). 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.[^94] Many of the licensees
in these services are individuals, and thus are not small entities. In
addition, due to the mostly unlicensed and shared nature of the spectrum
utilized in many 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.

**Wireless Service Providers**. The SBA has developed a small business
size standard for wireless firms within the two broad economic census
categories of \"Paging\"[^95] and \"Cellular and Other Wireless
Telecommunications.\"[^96] Under both categories, the SBA deems a
wireless business to be small if it has 1,500 or fewer employees. For
the census category of Paging, Census Bureau data for 2002 show that
there were 807 firms in this category that operated for the entire
year.[^97] Of this total, 804 firms had employment of 999 or fewer
employees, and three firms had employment of 1,000 employees or
more.[^98] Thus, under this category and associated small business size
standard, the majority of firms can be considered small. For the census
category of Cellular and Other Wireless Telecommunications, Census
Bureau data for 2002 show that there were 1,397 firms in this category
that operated for the entire year.[^99] Of this total, 1,378 firms had
employment of 999 or fewer employees, and 19 firms had employment of
1,000 employees or more.[^100] Thus, under this second category and size
standard, the majority of firms can, again, be considered small.

**Public Safety Radio Services**. Public Safety radio services include
police, fire, local government, forestry conservation, highway
maintenance, and emergency medical services.[^101] For small businesses
in this category, the above small business size standard applies to 1500
or fewer employees. There are a total of approximately 127,540 licensees
in these services. Governmental entities[^102] as well as private
businesses comprise the licensees for these services. All governmental
entities with populations of less than 50,000 fall within the definition
of a small entity.[^103]

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

We propose a licensing approach for the 401-402 MHz and 405-406 MHz wing
bands identical to that used for the existing MICS center band. Thus,
rather than require individual transmitter licensing, we propose to
authorize operation by rule within the Citizens Band (CB) Radio Service
under Part 95 of our Rules and pursuant to Section 307(e) of the
Communications Act.[^104] Under this proposal, licensing would be
accomplished through adherence to applicable technical standards and
other operating rules (unlicensed operations). We tentatively conclude
that this approach is beneficial because it would minimize the
administrative burden on prospective licensees as compared with an
individual licensing. We seek comment on this proposal. Commenters are
invited to address whether other licensing approaches should be
considered and discuss the relative benefits and disadvantages compared
to our proposal.

A.  **Steps Taken to Minimize Significant Economic Impact on Small
    Entities, and Significant Alternatives Considered**

The RFA requires an agency to describe any significant alternatives that
it has considered in reaching its proposed 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 resources available to small entities; (2) the
clarification, consolidation, or simplification of compliance or
reporting requirements under the rule for 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 small entities.[^105]

We propose to establish a new Medical Data Service (MEDS) under Part 95
that would encompass all medical devices permitted to operate in the
entire 401-406 MHz band. We seek comment on options concerning whether
and how the five megahertz of spectrum that would comprise this proposed
MEDS band could be divided among the evolving varieties of implanted and
body-worn medical transmitters, including low-power, low-duty-cycle
(LPLDC) devices without listen-before-talk (LBT).

For example, should both implantable and body-worn transmitters be
permitted to operate in all, or just selected portions, of the five
megahertz of the proposed 401-406 MHz MEDS band? Should the same
technical standards that govern the existing MICS center band
transmitters be applied uniformly across the entire band? Should an
adjustment in the permissible operating power of body-worn transmitters
be made to account for difference in body tissue attenuation as compared
with implantable devices? Similarly, should LPLDC devices without LBT be
permitted to operate throughout the entire five megahertz of the
proposed MEDS band or be limited to segments such as the 401-402 MHz and
405-406 wing bands? Why or why not? Commenters should explain the
rationale, and corresponding benefits and disadvantages, for whatever
approach is recommended. Are there any other factors that should be
considered with respect to distinguishing the applicable rules for
implantable, body-worn devices, and LPLDC transmitters? Should other
types of medical radiocommunication devices be considered for operation
in this proposed MEDS band? We especially seek small entity comment on
these issues.

**F. Federal Rules that May Duplicate, Overlap, or Conflict With the
Proposed Rule**

None.

**STATEMENT OF**

**CHAIRMAN KEVIN J. MARTIN**

Re: In the Matter of Investigation of the Spectrum Requirements for
Advanced Medical Technologies; Amendment of Parts 2 and 95 of the
Commission's Rules to Establish the Medical Device Radio Communications
Service at 401-402 and 405-406 MHz; DexCom, Inc. Request for Waiver of
the Frequency Monitoring Requirements of the Medical Implant
Communications Service Rules; Biotronik, Inc. Request for Waiver of the
Frequency Monitoring Requirements for the Medical Implant Communications
Service Rules; *Notice of Proposed Rulemaking, Notice of Inquiry and
Order*

The use of wireless technologies in implantable and body-worn medical
devices is improving and extending patients' lives. Today's item
supports continued development and deployment of these devices by
proposing the allocation of additional spectrum and greater flexibility
for medical radio devices. As demand for more advanced medical devices
increases, we should also be prepared to facilitate next-generation
solutions and to work with the Food and Drug Administration and other
agencies that play a role in their evolution. Our requests for
information on new medical radio technologies and inter-agency
collaboration will help us better anticipate future developments in this
field of medicine and thereby provide the best healthcare possible for
patients today and tomorrow.

**STATEMENT OF**

**COMMISSIONER MICHAEL J. COPPS**

*Re:* *Investigation of the Spectrum Requirements for Advanced Medical
Technologies*, Notice of Proposed Rulemaking, Notice of Inquiry, and
Order

Few uses of our spectrum could be more important than supporting new
medical technologies that can extend and improve lives.  Already, our
nation's medical researchers have developed extraordinary body-worn and
implanted devices that control heart rhythms to prevent attacks,
mitigate the tremors of neurological patients, and help control the
delivery of insulin to patients with diabetes.  Around the corner are a
whole host of equally awe-inspiring technologies -- devices that can
restore movement in paralyzed persons, improve sight among the
visually-impaired, and control artificial limbs by direct interfaces
with the brain and nervous system.  We all owe these scientists a great
measure of gratitude for their heroic efforts.

Wireless technologies are likely to play a key role in the development
of these and other medical devices.  The use of radiofrequencies allows
doctors to send signals to and recover data from subcutaneous and
implanted devices without the use of wires that are prone to infection
and other forms of failure.  Today's item seeks comment on how the
Commission can make spectrum available for these critically important
tasks, and I am happy to support it.  I would like to give special
thanks to our Office of Engineering and Technology, as well as our
colleagues at the Food and Drug Administration (FDA) and the National
Telecommunications and Information Administration (NTIA), for their hard
work in crafting this excellent and timely item.

**STATEMENT OF**

**COMMISSIONER DEBORAH TAYLOR TATE**

*Re*: *Investigation of the Spectrum Requirements for Advanced Medical
Technologies,* Notice of Proposed Rulemaking, Notice of Inquiry, and
Order.

Imagine a world in which:

-   A quadriplegic can again move her arms and legs;

-   A person with chronic depression never needs a pill;

-   The visually impaired can see with the assistance of a microchip;
    and,

-   An array of conditions such as Parkinson's disease, bipolar
    disorder, obsessive compulsive disorder, and even bulimia can be
    conquered with relative ease.

What once was possible only in science fiction is rapidly becoming
science fact through breakthroughs occurring in biomedical engineering
almost everyday.

The Commission's task in this item is about improving the quality of
life. Throughout my professional career and as a lifelong community
volunteer, I have tried to serve as an advocate for services which heal
the body, mind, and spirit. I am glad that I have another opportunity to
continue that commitment to healthier living in my role as a
Commissioner.

While medical devices that use the spectrum are not a brand new concept,
it is clear that greater and greater achievements lie ahead. Thus, this
item is critical to ensure that we properly facilitate the promises of
biomedical engineering in a manner that protects patients while still
giving doctors and innovators the flexibility they need to continue to
make even more stunning advances in the future.

**STATEMENT OF**

**COMMISSIONER ROBERT M. McDOWELL**

Re: Investigation of the Spectrum Requirements for Advanced Medical
Technologies, Amendment of Parts 2 and 95 of the Commission's Rules to
Establish the Medical Device Radio Communications Service at 401-402 and
405-406 MHz; DexCom, Inc. Request for Waiver of the Frequency Monitoring
Requirements of the Medical Implant Communications Service Rules;
Biotronik, Inc. Request for Waiver of the Frequency Monitoring
Requirements for the Medical Implant Communications Service Rules,
*Notice of Proposed Rulemaking, Notice of Inquiry and Order*

I am pleased that the Commission is undertaking this effort to reexamine
the spectrum requirements for advanced medical technologies, and I thank
the staff of the Office of Engineering and Technology for its work on
this item. Our goal -- to create an environment that fosters continuing
improvements in medical devices through flexible spectrum allocations
and minimum regulatory requirements -- is laudable.

I am delighted that the Commission will play a role in working to bring
cutting-edge technologies to fruition in order to improve the quality of
life for all Americans. The horizon is exciting.

-   For those with heart disease: these new technologies offer the
    promise of improved cardiac pacemakers and defibrillators that
    monitor and report on heart functions with increased sophistication;

-   for patients with sleep disorders, depression or other mental
    illnesses: the development of vests worn on the body that capture
    cardiopulmonary and other medical data and facilitate wireless
    transmission of the readings to health care providers in real-time;

-   for those with diabetes: the promise of implanted blood glucose
    sensors that would not only monitor and wirelessly transmit readings
    directly to health care providers, but would directly manage
    medications; and

-   for patients with eye disorders such as macular degeneration: the
    real potential for increased eye function through microchip
    technologies.

I am also pleased that the Commission seeks to permit multiple players
to operate in the medical device spectrum band. While we must be mindful
of the need to avoid potential harmful interference to other in-band
operations, facilitating competition in the medical device market is
particularly important given the ageing U.S. population (76 million baby
boomers will reach retirement age within the next decade), and the
corresponding need for an increased number of our citizens to
participate in more frequent health monitoring. I am hopeful that a
proliferation of devices will lead to decreased health care prices and
improved quality of care, while also allowing patients the ability to
lead more independent lives.

I look forward to working closely with the Chairman and all of my
Commission colleagues as we move forward. And, I encourage all
interested parties to join us in this exciting work.

[^1]: *See* Amendment of Parts 2 and 95 of the Commission's Rules to
    Establish the Medical Data Service at 401-402 MHz and 405-406 MHz,
    Petition for Rulemaking, filed by Medtronic, Inc., received by the
    Commission's Office of the Secretary on July 15, 2005, which
    initiated RM-11271 (Medtronic petition).

[^2]:  For example, the biomedical engineering research projects at the
    Alfred Mann Institute foresee progress toward implantable BIONic
    neurons (BIONs) that could provide precise interfaces between
    electronic controllers and muscles. Available online at
    <http://ami.usc.edu/projects/ami/projects/bion/>. *See also* Raja
    Mishra, *Implant Could Free Power of Thought for the Paralyzed,* The
    Boston Globe*,* October 9, 2004, available at
    http://www.wireheading.

    com/misc/implant.html.

[^3]:  In this concept, a tiny microchip containing thousands of
    microscopic solar cells converts light into electrical signals that
    travel through the optic nerve to the brain and are interpreted as
    an image. *See* Dan Roberts, *Microchip Implantation,* Macular
    Degeneration Support, March 2005.
    <http://www.mdsupport.org./library/chip.html>.

[^4]: Samuel K. Moore, *Psychiatry\'s Shocking New Tools*, IEEE
    Spectrum, March 2006.

[^5]: *Id*.

[^6]:  *See* *New Devices May Free Diabetics From Constant Monitoring*,
    Washington Post, April 23, 2006, p. A1. *See also,* Chappell Brown,
    *Real-World Implants Are Arriving,* EE Times, Sept. 12, 2005,
    available at
    http://www.eetimes.com/news/latest/showArticle.jhtml?articleID=170701430
    ("In the near term, electrodes that can be implanted and communicate
    with the nervous system are being used in products marketed by
    Medtronic Inc. (Minneapolis). Applications include controlling
    Parkinson's tremors, alleviating pain and controlling heart rhythms
    to avoid attacks."). *See also,* Ciaran Buckley, *SFI Invests
    EUR16.5m In Bio-Chip Research,* ENN ElectricNews.net, Sept. 7, 2005,
    available at http://www.electricnews.net/news.html?code=9636454.
    ("\[B\]io-chips will be used for cancer detection and assessing
    cardiac health, and will also be used in systems that monitor the
    coagulation of blood... \[D\]iagnostic medical devices being
    developed at the centre would help to make medicine more pro-active,
    helping health professionals and individuals to identify health
    issues before they become chronic problems.")

[^7]:  Henry Higgins, *Making Medical Diagnosis an Out-of-Body
    Experience,* March 2005, available at http://europe.el

    ecdesign.com/Articles/ArticleID/10023/10023.html.

[^8]:  The FDA is a public health service agency within the United
    States Department of Health and Human Services. The FDA assures the
    safety of foods and cosmetics, and the safety and efficacy of
    pharmaceuticals, biological products, and medical devices.
    Additional information on the FDA is available at
    [http://www.fda.gov](http://www.fda.gov/), and for device
    requirements at <http://www.fda.gov/cdrh/emc/index.html>.

[^9]: Part 95 of the Commission\'s rules define "medical implant
    transmitter" as a ". . . transmitter that operates or is designed to
    operate within the human body for the purpose of facilitating
    communications from a medical implant device."^?^ *See Appendix 1 to
    Subpart E of Part 95 -- Glossary of Terms* (following 47 C.F.R. §
    95.673).

[^10]:  Telemetry is the use of telecommunication for automatically
    indicating or recording measurements at a distance from the
    measuring instrument. 47 C.F.R. § 2.1.

[^11]:  *First Report and Order* in Docket No. 19478 and RM-1842
    (Amendment of Parts 2 and 91 of the Commission's Rules to Permit
    Medical Telemetry and Other Low-Power Uses of Offset Frequencies in
    the Business Radio Service), 41 F.C.C.2d 8 (1973).

[^12]:   *Report and Order* in ET Docket No. 99-255 and PR Docket No.
    92-235 (Amendment of Parts 2 and 95 of the Commission\'s Rules to
    Create a Wireless Medical Telemetry Service), 15 FCC Rcd 11206
    (2000) (*WMTS Order*). 47 C.F.R. § 95.401(e). (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.)

[^13]:   *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), 14 FCC Rcd 21040
    (1999) (*MICS Order*). 47 C.F.R. Part 95, Subpart I (Medical Implant
    Communications), and Subpart E (Technical Regulations).

[^14]: *See MICS Order* at para. 3.

[^15]:   *Order* in ET Docket No. 03-92 (Biotronik, Inc. Request for
    Waiver of the Frequency Monitoring Requirements for the Medical
    Implant Communications Service Rules), 19 FCC Rcd 4208 (2004)
    (*Biotronik Waiver*); *Order* in ET Docket No. 05-213 (DexCom, Inc.
    Request for Waiver of the Frequency Monitoring Requirements of the
    Medical Implant Communications Service Rules), FCC 06-1, released
    January 18, 2006 (*DexCom Waiver*). We additionally note that the
    Laboratory Division of the Commission\'s Office of Engineering and
    Technology also works closely with equipment and device
    manufacturers on an ongoing basis to facilitate grant of equipment
    certifications and authorizations for medical device transmitters
    operating on either a licensed and unlicensed basis, and to provide
    guidance on how to take measurements for compliance with the
    Commission's standards on human exposure to RF emissions.

[^16]: *See* n. 1, *supra*.

[^17]: Petition for Rule Making of Biotronik, Inc., filed June 16, 2006.
    This petition has been added to the record of this proceeding.

[^18]: *See* 47 C.F.R. § 15.242 and 47 C.F.R. § 15.241.

[^19]: 47 C.F.R. §§ 15.37(i), 90.203(a)(1).

[^20]: 47 C.F.R. § 95.1101-1129.

[^21]: *See* 47 C.F.R. § 15.205

[^22]: *See* Petition to Amend the Medical Implant Communications
    Service (MICS) Rules to add Inductive Telemetry at 90-110 KHz, filed
    February 21, 2006.

[^23]: 47 C.F.R. § 95.1209(a).

[^24]: The rules also provide for immediate transmission initiated by
    the medical implant transmitter in the case of a "medical implant
    event." 47 C.F.R. § 95.1209(b).

[^25]: *See* Medtronic Petition, Appendix A, at proposed section §§
    1.1307, 95.603(f).

[^26]:  *MICS Order* at 14 FCC Rcd 21055-21057, 21066.

[^27]:  47 C.F.R. § 95.628, *et seq*

[^28]: 47 C.F.R. § 95.628. This rule also authorizes MICS transmitters
    to operate on any frequency within the 402-405 MHz band, and limits
    the emission bandwidth from a MICS device to 300 kHz.

[^29]: 47 C.F.R. § 95.1211.

[^30]:  *MICS Order* at 21042-43.

[^31]: 47 C.F.R. § 2.106, footnote US 345

[^32]:  These devices were an implanted cardiac pacemaker manufactured
    by Biotronik, Inc. (Biotronik) and an implanted blood glucose
    monitor manufactured by DexCom, Inc. (DexCom). *See Biotronik
    Wavier, supra,* and *DexCom Waiver, supra*.

[^33]: *Id*.

[^34]:  *See* n.1 *supra*.

[^35]: *Id.* at i - ii, *et seq*.

[^36]: Medtronic Petition at 4, referring to Recommendation ITU-R*,*
    SA.1346, *Sharing Between the Meteorological Aids Service and
    Medical Implant Communications Service (MICS) Operating in the
    Mobile Service in the Frequency Band 401-406 MHz.*

[^37]:  *Public Notice*, August 24, 2005, Report No. 2725 (RM-11271). A
    list of the parties filing comments and reply comments is attached
    as Appendix A.

[^38]:  *See* DePuy Orthopaedics Comments at 1; Intel Reply Comments at
    2 and 5; Medtronic Comments at 5; Medtronic Reply Comments at 1 and
    14; Scanlon Comments at 1; Transoma Medical Comments at 1; Zarlink
    Comments at 1; DexCom Comments at 1.

[^39]: *See* Biotronik Reply Comments at 2.

[^40]: *See* n. 17, *supra*.

[^41]:  *Id.* at 3.

[^42]:  *See* Transoma Comments at 1. *See* Zarlink Comments at 2.

[^43]:  *See* DexCom Reply Comments at 1-2.

[^44]: *See* Biotronik Reply Comments at 2.

[^45]: Biotronik Petition for Rule Making at 2, 5.

[^46]: In the United States, the 401-406 MHz band is allocated to the
    meteorological aids service (METAIDS) on a primary basis for Federal
    and non‑Federal use and transmissions are limited to radiosondes and
    associated ground transmitters. (The METAIDS is a radiocommunication
    service used for meteorological, including hydrological, observation
    and exploration. A radiosonde is an automatic radio transmitter in
    the METAIDS usually carried on an aircraft, free balloon, kit or
    parachute, and which transmits meteorological data. Radiosondes
    worldwide are launched each day to provide soundings data that
    contribute to global reports of air movement, pressure, and
    temperature. Computer models use this information to produce weather
    forecasts. While the 401-406 MHz band is allocated to the METAIDS on
    a primary basis in all Regions in the ITU *Radio Regulations*,
    transmissions are not limited to radiosondes and associated ground
    transmitters.) The Departments of Commerce (National Weather
    Service), Defense, and Energy are the primary users of this METAIDS
    allocation. (As of January 7, 2006, NTIA has authorized 52
    radiosonde station assignments, 47 radiosonde ground station
    assignments, and 12 radar beacon precipitation gauge station
    assignments in the 401-406 MHz band. Non-Federal use of this METAIDS
    allocation has been limited to experimental license applications.)
    The 401-403 MHz band is also allocated to the
    meteorological-satellite (METSAT) and Earth exploration-satellite
    services (Earth-to-space) on a primary basis for Federal use and on
    a secondary basis for non-Federal use. As of January 7, 2006, NTIA
    has authorized 5,094 Federal assignments for transmitting earth
    stations in the METSAT and 18 Federal assignments for transmitting
    earth stations in the Earth Exploration Satellite Service (EESS).
    While the FCC has issued several hundred experimental licenses for
    non-Federal earth stations in the METSAT that transmit to Federal
    space stations in the 401-403 MHz band, no licenses have been issued
    in the EESS. *See* <http://www.nws.noaa.gov/oh/hads/>. This METSAT
    allocation is used by Federal and non-Federal earth stations (known
    as data collection platforms) that transmit weather information to
    Federal space stations (*e.g.*, National Oceanic and Atmospheric
    Administration and Geostationary Operational Environmental Satellite
    space stations). With regard to TT&C (tracking, telemetry and
    command) use of the 401-402 MHz band, the FCC has issued two
    licenses for NGSO space stations and four licenses for earth
    stations (each receive a 60 kHz emission centered on 401.5 MHz).
    (Specifically, Orbital Imaging Corporation (Orbimage) operates a
    high-resolution satellite imagery system in low-Earth orbit (LEO);
    space telemetry is received at earth stations in Barrow, AK (call
    sign E980376) and Dulles, VA (call sign E980375). EarthWatch
    Incorporated operates a LEO remote-sensing satellite system; space
    telemetry is received at earth stations in Fairbanks, AK (call sign
    E950499) and Longmont, CO (call sign E950498). NTIA has authorized
    one assignment for space stations in non-geostationary orbit (NGSO)
    transmitting telemetry to earth stations in this band.) In addition,
    the 401-402 MHz band is allocated to the space operation service
    (space-to-Earth) on a primary basis for Federal and non-Federal use.
    (In the ITU *Radio Regulations*, the 401-406 MHz band is allocated
    to the mobile except aeronautical mobile service on a secondary
    basis in all Regions. 47 C.F.R. § 2.106.) The 402-405 MHz band is
    allocated to the MICS on a secondary basis as indicated above. The
    402-406 MHz band is allocated to the mobile except aeronautical
    mobile service on a secondary basis. This allocation is codified in
    footnotes US345 and G6 to the Commission\'s Table of Frequency
    Allocations, which also limits the use of the allocation to Federal
    and non-Federal MICS stations in the 402-405 MHz band and to
    "military tactical fixed and mobile operations" in the 403-406 MHz
    band. (47 C.F.R. § 2.106, footnotes US345, G6.) We are unaware of
    any airborne use of the 403-406 MHz band and have requested that
    NTIA investigate this matter with view toward the deletion of the
    aeronautical mobile service. In the context of military tactical
    fixed operations, NTIA has informed us that this term actually means
    temporary fixed.)

[^47]:  *See* Medtronic Petition, Appendix A, at proposed rule sections
    95.633(h). For MICS transmitters, the maximum authorized emission
    bandwidth is 300 kHz. 47 C.F.R. § 95.633(e).

[^48]: The Medtronic petition suggests a standard by which emissions
    more than 50 kHz away from the fundamental emission would need to be
    attenuated by at least 20 dB; and emissions outside of the
    designated bands would need to be attenuated to 200 µV/m at 3 meters
    in the frequency ranges 216-400.9 MHz and 406-960 MHz. This is
    similar to the rules adopted for MICS transmitters, except that the
    field strength limit of 200 µV/m at 3 meters would have to be
    achieved in within a narrower 100 kHz span (400.9-401 MHz), instead
    of the 250 kHz span under the MICS rules. []{.mark}

[^49]: *See* Medtronic Petition, Appendix A, at proposed rule sections
    95.639(i).

[^50]: By comparison, one of the devices permitted by the *Biotronik
    Waiver* transmits in bursts of up to 280 milliseconds, repeated ten
    times per day, at a maximum power of 100 nanowatts on a single 40
    kHz bandwidth channel. The blood glucose monitor permitted by the
    *DexCom Waiver* also operates on only one frequency with a 120 kHz
    bandwidth, with a power of 10 microwatts (-20dBm) and for only 6-9
    milliseconds every five minutes.

[^51]: *See DexCom Order* at para 18.

[^52]: *See* Medtronics petition, proposed Appendix 1 to Subpart E to
    Part 95 - Glossary of Terms.

[^53]:  Section 95.603(f) presently requires that applications for
    equipment authorization must contain a "finite difference time
    domain (FDTD) computational modeling report." Medtronic's proposal
    would also allow, as an alternative to the FDTD requirement, "a
    report based on another technique accepted by the Commission." *See*
    Medtronic Petition, Appendix A, at proposed section §§ 1.1307,
    95.603(f).

[^54]:  Proposed Changes in the Commission's Rules Regarding Human
    Exposure to Radiofrequency Electromagnetic Fields, ET Docket No.
    03-137, *Notice of Proposed Rule Making*, 18 FCC Rcd 13187 (2003),
    available at
    http://hraunfoss.fcc.gov/edocs_public/attachmatch/FCC-03-132A1.doc.

[^55]: See *MICS Order* at para 3.

[^56]: *Id.*

[^57]: 47 C.F.R. § 15.205.

[^58]: The 90-110 kHz band is allocated for Radionavigation (Loran-C)
    service by both Federal and non-Federal use on a shared, primary
    basis. (47 C.F.R. §2.106.) Non-federal use in this band consists of
    aviation and Private Land Mobile services under Parts 87 and 90
    respectively.

[^59]: Guidant petition at 5. Guidant further states that their medical
    devices produce radiated emissions in the 90-110 kHz band as a
    'by-product' of the inductive coupling technique employed to
    communicate with the devices.^?^ However, Guidant further states
    that the level of emissions from these inductive implants is
    typically 50-90 dB below the limits of Section 15.209.

[^60]: *See* Guidant petition generally.

[^61]: Guidant petition at 5.

[^62]: We note that we would seek the concurrence of the National
    Telecommunications and Information Administration (NTIA) before any
    action, such as those suggested in this paragraph, that would impact
    a restricted band allocated for Federal Government use.

[^63]: *See* para 8*, supra.*

[^64]: *Request for Extension of Waiver*, December 12, 2005.

[^65]: *See, e.g.*, Alfred E. Mann Foundation at
    http://www.aemf.org/index.html.

[^66]: *See, e.g.[,]{.underline}* <http://www.media.mit.edu/wearables/>;
    http://www.vivometrics.com/site/system.html.

[^67]: *See, e.g.,* 47 C.F.R. § 95.631 ("Emission Types").

[^68]: 47 C.F.R. § 95.631 (h)

[^69]:  47 C.F.R. § 15.5.

[^70]:  See *WMTS Order,* 15 FCC Rcd 11206, at para 6.

[^71]: *Id.* at para 3.

[^72]: 47 C.F.R. §§ 15.37(i), 90.203(a)(1).

[^73]: 47 C.F.R. § 95.1101-1129.

[^74]: FCC Part 15, Subpart D, 47 C.F.R. §§ 15.301 through 15.323.

[^75]:  We note, however, that some researchers and practitioners
    continue to debate whether concerns about interference in settings
    such as hospitals, for example, from devices like pagers and cell
    phones, have been overestimated. *See* *No hazard to hospitals? Fear
    that cell phones cause failure of vital machines in medical
    facilities is a myth, says author of new study*, Newsday.com,
    Health/Science, by Delthia Ricks, February 6, 2006, available at
    http://www.newsday.com/news/health/ny-hsfone064615861feb06,0,2835197.story.

[^76]:  We also note that the National Institute of Standards and
    Technology (NIST) has certain programs designed to assist the
    healthcare industry in the evaluation and application of wireless
    technologies for medical applications. *See*
    [[http://w3.antd.nist.gov/Health.shtml]{.underline}](http://w3.antd.nist.gov/Health.shtml).

[^77]: We note that such a site already exists for medical devices and
    adverse event reports to FDA, which is required of medical device
    manufacturers (and certain health care facilities or clinicians) in
    cases of serious injury or death.
    http://www.fda.gov/medwatch/how.htm.

[^78]:  Public Law 107-198, *see* 44 U.S.C. 3506(c)(4).

[^79]: ^ ?^ *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. 847 (1996).

[^80]:  *See* 5 U.S.C. § 603(a).

[^81]:  *Id.*

[^82]:  Telemetry is the use of telecommunication for automatically
    indicating or recording measurements at a distance from the
    measuring instrument. 47 C.F.R. § 2.1.

[^83]: Part 95 of the Commission\'s rules define "medical implant
    transmitter" as a " . . . transmitter that operates or is designed
    to operate within the human body for the purpose of facilitating
    communications from a medical implant device."^?^ *See Appendix 1 to
    Subpart E of Part 95 -- Glossary of Terms* (following 47 C.F.R. §
    95.673). The term \"body-worn\" is not defined by our current rules,
    however, as discussed in Rulemaking herein, we propose to adopt an
    analogous definition for medical body-worn transmitters namely, a
    "transmitter intended to be placed on or in very close proximity
    (i.e., 6 centimeters or less) to the human body used to facilitate
    communications from a medical body-worn or implanted device."

[^84]:  5 U.S.C. § 603(b)(3).

[^85]:  5 U.S.C. § 601(6).

[^86]:  5 U.S.C. § 601(3) (incorporating by reference the definition of
    "small business concern" in 15 U.S.C. § 632). Pursuant to the RFA,
    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." 5 U.S.C. § 601(3).

[^87]:   Small Business Act, 15 U.S.C. § 632 (1996).

[^88]: *See* SBA, Programs and Services, SBA Pamphlet No. CO-0028, at
    page 40 (July 2002).

[^89]: 5 U.S.C. § 601(4).

[^90]: Independent Sector, The New Nonprofit Almanac & Desk Reference
    (2002).

[^91]: 5 U.S.C. § 601(5).

[^92]: U.S. Census Bureau, Statistical Abstract of the United States:
    2006, Section 8, page 272, Table 415.

[^93]: We assume that the villages, school districts, and special
    districts are small, and total 48,558. *See* U.S. Census Bureau,
    Statistical Abstract of the United States: 2006, section 8, page
    273, Table 417. For 2002, Census Bureau data indicate that the total
    number of county, municipal, and township governments nationwide was
    38,967, of which 35,819 were small. *Id.*

[^94]: 47 CFR Part 90.

[^95]: 13 C.F.R. § 121.201, NAICS code 517211.

[^96]: 13 C.F.R. § 121.201, NAICS code 517212.

[^97]: U.S. Census Bureau, 2002 Economic Census, Subject Series:
    "Information," Table 5, Employment Size of Firms for the United
    States: 2002, NAICS code 517211 (issued Nov. 2005).

[^98]: *Id.* The census data do not provide a more precise estimate of
    the number of firms that have employment of 1,500 or fewer
    employees; the largest category provided is for firms with "1000
    employees or more."

[^99]: U.S. Census Bureau, 2002 Economic Census, Subject Series:
    "Information," Table 5, Employment Size of Firms for the United
    States: 2002, NAICS code 517212 (issued Nov. 2005).

[^100]: *Id.* The census data do not provide a more precise estimate of
    the number of firms that have employment of 1,500 or fewer
    employees; the largest category provided is for firms with "1000
    employees or more."

[^101]: With the exception of the special emergency service, these
    services are governed by Subpart B of part 90 of the Commission's
    Rules, 47 C.F.R. §§ 90.15-90.27. The police service includes
    approximately 27,000 licensees that serve state, county, and
    municipal enforcement through telephony (voice), telegraphy (code)
    and teletype and facsimile (printed material). The fire radio
    service includes approximately 23,000 licensees comprised of private
    volunteer or professional fire companies as well as units under
    governmental control. The local government service that is presently
    comprised of approximately 41,000 licensees that are state, county,
    or municipal entities that use the radio for official purposes not
    covered by other public safety services. There are approximately
    7,000 licensees within the forestry service which is comprised of
    licensees from state departments of conservation and private forest
    organizations who set up communications networks among fire lookout
    towers and ground crews. The approximately 9,000 state and local
    governments are licensed to highway maintenance service provide
    emergency and routine communications to aid other public safety
    services to keep main roads safe for vehicular traffic. The
    approximately 1,000 licensees in the Emergency Medical Radio Service
    (EMRS) use the 39 channels allocated to this service for emergency
    medical service communications related to the delivery of emergency
    medical treatment. [47 CFR §§
    90.15](http://www.westlaw.com/Find/Default.wl?rs=++++1.0&vr=2.0&DB=1000547&DocName=47CFRS90.15&FindType=L)-90.27.
    The approximately 20,000 licensees in the special emergency service
    include medical services, rescue organizations, veterinarians,
    handicapped persons, disaster relief organizations, school buses,
    beach patrols, establishments in isolated areas, communications
    standby facilities, and emergency repair of public communications
    facilities. [47 CFR §§
    90.33](http://www.westlaw.com/Find/Default.wl?rs=++++1.0&vr=2.0&DB=1000547&DocName=47CFRS90.33&FindType=L)-90.55.

[^102]: 47 CFR § 1.1162.

[^103]: 5 U.S.C. § 601(5).

[^104]:  *See* Medtronic Petition at i, 16, and Appendix A, at proposed
    section § 95.1601. We note that 47 U.S.C. § 307(e)(3) provides that
    the term \"citizens band radio service\" shall have the meaning
    given it by the Commission by rule. 47 U.S.C. § 307(e)(1) provides
    that upon determination by the Commission that an authorization
    serves the public interest, convenience, and necessity, the
    Commission may by rule authorize the operation of radio stations
    without individual licenses in the citizens band radio service.

[^105]:  *See* 5 U.S.C. § 603(c).