Spectrum Requirements for Advanced Medical Technologies, 22696-22710 [E9-11063]

Agencies

• FEDERAL COMMUNICATIONS COMMISSION

[Federal Register Volume 74, Number 92 (Thursday, May 14, 2009)]
[Rules and Regulations]
[Pages 22696-22710]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-11063]


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FEDERAL COMMUNICATIONS COMMISSION

47 CFR Parts 1, 2 and 95

[ET Docket Nos. 06-135, 05-213 and 03-92, RM-11271; FCC 09-23]


Spectrum Requirements for Advanced Medical Technologies

AGENCY: Federal Communications Commission.

ACTION: Final rule.

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SUMMARY: This document establishes a new Medical Device 
Radiocommunication Service (MedRadio Service) of the Commission's 
rules. This new service incorporates the existing Medical Implant 
Communications Service (MICS) ``core'' band at 402-405 MHz, and also 
includes two megahertz of newly designated spectrum in the adjacent 
``wing'' bands at 401-402 MHz and 405-406 MHz. The MedRadio Service 
will accommodate the operation of body-worn as well as implanted 
medical devices, including those using either listen-before-talk 
(``LBT'') frequency monitoring or non-LBT spectrum access methods, in 
designated portions of the 401-406 MHz band.

DATES: Effective August 12, 2009.

FOR FURTHER INFORMATION CONTACT: Gary Thayer, (202) 418-2290, e-mail 
Gary.Thayer@fcc.gov.

SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Report 
and Order, ET Docket Nos. 06-135, 05-213, and 03-92, RM-11271, FCC 09-
23, adopted March 19, 2009, and released March 20, 2009. The full text 
of this document is available on the Commission's Internet site at 
https://www.fcc.gov. It is also available for inspection and copying 
during regular business hours in the FCC Reference Center (Room CY-
A257), 445 12th St., SW., Washington, DC 20554. The full text of this 
document also may be purchased from the Commission's duplication 
contractor, Best Copy and Printing Inc., Portals II, 445 12th St., SW., 
Room CY-B402, Washington, DC 20554; telephone (202) 488-5300; fax (202) 
488-5563; e-mail FCC@BCPIWEB.COM.

[[Page 22697]]

Summary of the Report and Order

    1. Overview. In July 2006, the Commission adopted a Notice of 
Proposed Rulemaking (NPRM), Notice of Inquiry (NOI) and Order--
collectively, the MedRadio NPRM. In the MedRadio NPRM, the Commission 
proposed to establish a new service for medical radiocommunication 
devices to better accommodate the varieties of new implantable and 
body-worn medical devices.
    2. In this Report and Order, the Commission decided to establish a 
new Medical Device Radio-communication Service (MedRadio Service) under 
part 95 of the Commission's rules. Under the rules adopted by the 
Commission in this Report and Order, this new service incorporates the 
existing Medical Implant Communications Service (MICS) ``core'' band at 
402-405 MHz, and also includes two megahertz of newly designated 
spectrum in the adjacent ``wing'' bands at 401-402 MHz and 405-406 MHz. 
Thus, the MedRadio Service will provide a total of five megahertz of 
contiguous spectrum on a secondary basis and non-interference basis for 
advanced wireless medical radiocommunication devices used for 
diagnostic and therapeutic purposes in humans. In addition, the 
MedRadio Service will accommodate the operation of body-worn as well as 
implanted medical devices, including those using either listen-before-
talk (``LBT'') frequency monitoring or non-LBT spectrum access methods, 
in designated portions of the 401-406 MHz band.
    3. The Commission found that the new MedRadio spectrum in the 401-
402 MHz and 405-406 MHz wing bands is well suited for use on a 
secondary basis by the medical implant and body-worn devices covered by 
this Order for several reasons. First, these frequencies offer the same 
propagation, availability, and compatibility characteristics that were 
found to be favorable for the MICS in the 402-405 MHz core band. In 
addition, this new designation will result in a continuous span of 
spectrum (from 401-406 MHz) that matches the five-megahertz of spectrum 
that is also designated internationally for similar use by medical 
implant and body-worn devices.
    4. The Commission noted that the service and technical rules 
adopted in this Report and Order for the MedRadio Service are based 
upon the existing MICS rules, and include modified spectrum sharing 
requirements in the new wing bands. The new rules will permit the use 
of both medical implant devices and medical body-worn devices in 
specified segments of the 401-406 MHz band.
    5. The Commission found that these new MedRadio sharing rules will 
provide a greater degree of flexibility than is permitted by the 
existing medical implant rules, while also assuring spectrum use 
compatibility among different device types. The Commission further 
found that the new designation in the wing bands will provide the 
additional shared spectrum that is urgently needed for operation of 
both implant and body-worn devices. The Commission stated its further 
belief that the MedRadio rules adopted in this Order should encourage 
the continuing use of the legacy MICS core band predominantly for life-
critical applications, such as those served by the existing population 
of medical implant devices presently used.
    6. With respect to the potential for interference to incumbent 
users of the 401-402 MHz and 405-406 MHz wing bands arising from the 
operation of MedRadio devices, the Commission concluded that the 
potential for such interference is negligibly small. The Commission 
noted that, in the United States, the 401-406 MHz band is allocated for 
various Federal and non-Federal uses on a primary basis, and the 402-
405 MHz band is allocated for mobile, except mobile aeronautical, 
service on a secondary basis, with use limited to MICS. The Commission 
determined that, given the ultra low power limits and intermittent 
operating modes that will be used by these medical devices, and the 
expectation of large separation distances, there is little likelihood 
that these medical devices could cause harmful interference to 
incumbent operations.
    7. With respect to the potential for harmful effects to MedRadio 
devices due to received interference from incumbent users, the 
Commission observed that it would be beneficial if MedRadio devices 
employed robust designs. For example, the Commission noted that 
MedRadio medical devices--particularly those devices used for life 
critical and time-sensitive applications--might need to employ a 
variety of error detection and correction techniques, frequency 
monitoring capabilities, and re-transmission protocols.
    8. In broader terms, the Commission determined that the additional 
spectrum and enhanced flexibility afforded in the new rules will 
promote the accelerated development of newer generations of advanced 
medical device technologies. These advances, the Commission found, will 
herald dramatic improvements in therapeutic/diagnostic patient care and 
quality of life for countless individuals. The Commission also noted 
that the MedRadio designation and rules adopted in this Order are 
harmonized for the most part in their general approach with similar 
European Telecommunication Standards Institute (ETSI) standards 
relating to use of the 401-406 MHz band by medical implant and body-
worn devices in other regions of the world. The Commission stated its 
belief that such harmonization will serve the public interest by 
offering Americans greater confidence of reliable device operation 
while traveling abroad, and conversely, by offering similar confidence 
for foreign visitors to the United States. The Commission also 
determined that economies of scale resulting from harmonized rules for 
domestic manufacturers seeking to compete in the world market should 
foster a reduction of device prices, thus making the benefits of such 
technologies more widely available and affordable for the American 
public.
    9. Licensing. Consistent with the existing MICS licensing scheme, 
the Commission decided that the new MedRadio service at 401-406 MHz 
will be governed under Part 95 of the Commission's rules, thus 
providing for license-by-rule operation throughout the 5 megahertz 
band. The Commission concluded that this approach minimizes regulatory 
procedures and will facilitate the more expeditious deployment of new 
generations of beneficial wireless medical devices in these bands that 
can improve the quality of life for countless Americans, thus serving 
the public interest, convenience and necessity. The Commission also 
decided that the operation of medical devices in the MedRadio band will 
be on a secondary, non-interference basis with respect to other 
authorized services and as such they must accept harmful interference 
from the systems operating in those services. MedRadio devices will 
operate on a shared, non-exclusive basis with respect to each other.
    10. Definitions--Implant and Body-worn Devices. In order to be 
deemed a medical body-worn device or medical body-worn transmitter, the 
Commission required that the antenna of the associated patient-worn 
device be placed upon or in very close proximity (e.g., within a few 
centimeters) to the body. In order to be classified as a medical 
implant transmitter or medical implant device, the Commission required 
that the transmitting antenna of the patient device must itself be 
implanted wholly within the body--which would include any point below 
the skin, or more deeply within the body. The Commission retained the

[[Page 22698]]

existing definitions for medical implant devices.
    11. Authorized Frequencies for Implant and Body-Worn Devices. The 
Commission concluded that implanted devices will be permitted in both 
the existing MICS core band at 402-405 MHz, as well as in the wing 
bands at 401-402 MHz and 405-406 MHz. This will allow medical implant 
devices to operate anywhere in the 401-406 MHz band--but subject to 
different technical requirements in the core and wing bands.
    12. The Commission decided, with one exception, to permit body-worn 
devices to operate only in the wing bands at 401-402 MHz and 405-406 
MHz. Thus, in the new MedRadio wing bands, both implant and body-worn 
devices will be allowed to operate--under common technical requirements 
for each--throughout both the 401-402 MHz and 405-406 MHz frequency 
range. The Commission stated its belief this approach will serve to 
accommodate a greater variety of implant and body-worn devices. The 
Commission also observed that, by preserving the core band at 402-405 
MHz primarily for communications involving deeply implanted devices, 
these frequencies would likely continue to be used largely for life-
critical medical devices such as cardiac defibrillators.
    13. As an exception to the general rule for body-worn devices, the 
Commission decided to permit the operation in the core band of 
temporary body-worn devices that are used to evaluate the efficacy of 
an implanted medical device.
    14. The Commission determined that allowing the operation of such 
temporary body-worn devices will enhance the therapeutic and diagnostic 
options available to patients. In particular, the Commission noted that 
this will allow physicians to better evaluate the efficacy of proposed 
treatments involving implanted devices prior to actual device 
implantation. The Commission decided to permit the operation of such 
temporary body-worn devices on any frequency in the 402-405 MHz core 
band provided that: (1) Such external operation is limited solely to 
evaluating with a patient the efficacy of a fully implanted permanent 
medical device that is intended to replace the temporary body-worn 
device; (2) RF transmissions from the external device must cease 
following the patient evaluation period, which may not exceed 30 days, 
except where a health care practitioner determines that additional time 
is necessary due to unforeseen circumstances; (3) the maximum output 
power of the external, temporary body-worn device shall not exceed 200 
nW EIRP; and (4) the external device must comply fully with all other 
MedRadio rules described throughout the core 402-405 MHz band.
    15. The Commission declined to explicitly limit the core band to 
life-critical and time-sensitive applications, or to designate the wing 
bands for non-life-critical, non-time sensitive applications. The 
Commission said that its decision to limit the core band primarily to 
communications involving implanted devices, coupled with the technical 
rules adopted for use of the core and wing bands will achieve much the 
same result, while providing greater flexibility for device 
manufacturers and practitioners. The Commission determined that leaving 
the ultimate decision on these matters to health care professionals and 
medical device manufactures, in concert with FDA-required risk 
management processes, would result in better and more flexible use of 
this scarce spectrum resource.
    16. Permissible Communications and Operator Eligibility. The 
Commission concluded that the new MedRadio service will be governed by 
the same operator eligibility and permissible communications 
requirements that pertain to the legacy MICS. According to the 
Commission, this will result in a more beneficial use of the spectrum 
than alternative approaches.
    17. More specifically, the Commission decided that MedRadio devices 
may be used only by persons for diagnostic and therapeutic purposes, 
and only when provided for such purposes to a human patient under the 
direction of a duly authorized health care professional. Furthermore, 
the Commission limited the MedRadio service to the transmission of non-
voice data. MedRadio programmer/control transmitters may not relay 
information on MedRadio frequencies to a receiver that is not included 
with a MedRadio device. The Commission concluded that these 
requirements are central to maintaining the originally intended 
character and utility of this spectrum, which the Commission found has 
proven to be of significant benefit to many patients over the years.
    18. The Commission declined to adopt rules in this Order that would 
permit the operation of wireless hearing aids in the upper portion of 
the lower MedRadio wing band. However, in recognition of the important 
public interest benefits associated with this proposal, the Commission 
welcomed additional technical submissions or revisions to address 
whether this or some other band(s) could accommodate various types of 
hearing aid devices, and stated that it would consider developing a 
record through a notice of proposed rulemaking to more fully analyze 
these matters.
    19. The Commission also declined to allow the use of MedRadio 
devices in connection with animal test subjects in the course of human 
drug research. The Commission found that such testing would not, in and 
of itself, directly perform any diagnostic or therapeutic function for 
a human patient. In contrast, the Commission observed that, since its 
creation, the legacy MICS had been explicitly reserved for use by 
devices performing diagnostic and therapeutic functions with human 
patients and only when such use has been duly authorized by a health 
care professional. It further found that changing the eligibility 
requirements to permit animal test subject use would constitute a major 
departure from these underlying requirements and that such a departure 
did not appear to be warranted based upon the record in this 
proceeding. From a procedural perspective, the Commission further 
stated that the MedRadio NPRM neither proposed, nor sought comment on, 
modifying these basic service and eligibility provisions; and that it 
particularly did not address the specific question at issue here of 
whether use of the MICS/MedRadio frequencies should be extended to 
animal testing. Thus, the Commission concluded that it had an 
insufficient substantive record or procedural notice upon which to 
pursue the matter of animal test subjects.
    20. MedRadio channels. The Commission decided to generally carry 
forward the MICS rules into the new MedRadio Service. Under the 
existing rules, no particular channeling scheme is specified for the 
operation of MICS devices. Instead, a ``channel'' is simply defined as 
any continuous segment of spectrum used by a medical device. Thus, a 
MedRadio device may transmit on any center frequency so long as the 
maximum authorized emission bandwidth is not exceeded. The Commission 
stated its belief that this approach is beneficial because it would 
continue to provide the greater flexibility that device manufacturers 
now use as compared with a rigid channeling scheme.
    21. Emission Bandwidth. With respect to the new MedRadio wing bands 
at 401-402 MHz and 405-406 MHz, the Commission concluded that a 100 
kilohertz maximum authorized emission bandwidth in the limited space of 
the one-megahertz wide wing bands will foster more intensive spectrum 
utilization by a greater number of devices as compared with a 300

[[Page 22699]]

kilohertz maximum bandwidth. The Commission determined that this 
smaller bandwidth would allow more devices to use the wing bands on 
non-overlapping spectrum. In addition, the Commission found that this 
bandwidth will also serve to minimize interference potential from other 
MedRadio devices, particularly in light of the fact that both LBT and 
non-LBT devices will share the entire wing bands.
    22. As one exception to the general bandwidth requirement for the 
wing bands, the Commission decided to allow up to a 150 kilohertz 
maximum authorized emission bandwidth at 401.85-402 MHz. In reaching 
this decision, the Commission recognized that some body worn devices, 
such as the glucose monitoring devices that are now operating in the 
core band under a waiver, need a slightly wider emission bandwidth. 
Thus, the Commission found that its decision here to allow a slightly 
wider emission bandwidth at the upper edge of the 401-402 MHz wing band 
will facilitate transitioning such devices now operating under rule 
waivers out of the core band. In addition, the Commission observed that 
the narrower bandwidth for the wing bands, is expected to be better 
suited for non-life-critical devices--namely, those with less severe 
battery life constraints that are tailored for operation with lower 
bandwidth data streams utilizing a relatively greater number of longer 
data transmission sessions as compared with devices used in the core 
band.
    23. For the core band at 402-405 MHz, the Commission decided to 
maintain the existing maximum authorized emission bandwidth of 300 
kilohertz. The Commission found that, relative to the 100 kilohertz 
bandwidth it adopted for the wing bands, this 300 kilohertz bandwidth 
will better facilitate more data-intensive transmissions of shorter 
duration which tend to be more energy efficient, and thus prolong 
battery life for implants. This will also support higher data 
transmission rates than could be accommodated by the maximum authorized 
emission bandwidth of 100 kilohertz channels of the wing bands, and 
thus may be more desirable for certain applications. The Commission 
found that such characteristics are especially beneficial in extending 
the battery life of deep implant devices.
    24. The Commission decided that it would continue to permit 
MedRadio transmitters to utilize full duplex or half duplex 
communications if the total amount of bandwidth used by all of the 
MedRadio channels employed by a MedRadio device during a MedRadio 
communications session does not exceed the maximum authorized emission 
bandwidth (i.e., 100 kilohertz in the wing bands and 300 kilohertz in 
the core band). Moreover, smaller bandwidths may be employed by a 
single MedRadio device so long as the device adheres to all other EIRP 
and unwanted emission limits. For example, a single MedRadio device 
operating in the wing bands could be designed to operate nominally on 
two channels, each having a maximum emission bandwidth of 50 kilohertz, 
because the communications session would, in aggregate, be 100 
kilohertz. The Commission noted that, in essence, these provisions 
carry forward the existing channel use provisions of the MICS rules 
into the new MedRadio rules.
    25. Frequency monitoring requirement. In the Report and Order, the 
Commission observed the current MICS rules require that the programmer/
control transmitter associated with a medical implant device in the 
402-405 MHz band must incorporate a frequency monitoring mechanism to 
monitor the channel or channels that the medical device transmitters 
intend to occupy. The Commission further stated its belief that an LBT 
frequency monitoring requirement is beneficial because it facilitates 
spectrum sharing among many uncoordinated devices and can reduce the 
likelihood of harmful interference from federal systems that are 
allocated on a primary basis. Thus, the Commission decided to maintain 
the current frequency monitoring protocol specified in the form MICS 
rules as a general requirement for implant devices permitted throughout 
the entire 401-406 MHz MedRadio core band, as well as for body-worn 
devices permitted in the new wing bands. In addition, the Commission 
also extended the ``medical implant event'' exception of the current 
rules to LBT-enabled implant devices operating throughout the 401-406 
MHz MedRadio band.
    26. In further recognition of the potential advantages of non-LBT 
spectrum access methods for certain low power, low duty cycle (LP-LDC) 
devices--particularly, in terms of extended battery life, reduced 
complexity, and lower device cost to patients--the Commission decided 
to permit the use of non-LBT spectrum access methods in the wing bands, 
with certain transmitter power and duty cycle limits, by both implant 
and body-worn devices. In addition, the Commission permitted the use of 
non-LBT spectrum access methods for implant devices that operate with 
an emission bandwidth not exceeding 300 kilohertz centered at 403.65 
MHz in the existing core band with certain transmitter power and duty 
cycle limits. Finally, the Commission also decided to permit the 
operation on any of the frequencies in the 402-405 MHz band of 
temporary body-worn transmitting devices that are used solely during a 
limited patient evaluation period in order to determine the suitability 
of a fully implanted device, provided that they fully comply with all 
other MedRadio rules applicable to the band.
    27. Transmitter power and duty cycle. The Commission limited the 
maximum EIRP of LBT-enabled implant devices throughout the 401-406 MHz 
band and LBT-enabled body-worn medical devices in the wing bands to 25 
microwatts EIRP. The Commission determined that, as with the original 
MICS rules, this limit is intended to ensure efficient spectrum sharing 
and compatibility among multiple uncoordinated devices. Furthermore, 
the 25 microwatt limit will maintain continuity with the present EIRP 
limit and LBT frequency monitoring requirement for the core band (which 
we also maintain under the new MedRadio rules) that has served well for 
spectrum access.
    28. With respect to access to the 402-405 MHz band by non-LBT 
devices, the Commission found that the convergence of comments in the 
record, particularly subsequent to the adoption by ETSI of similar 
standards, supported permitting operation by such devices with a total 
emission bandwidth not exceeding 300 kilohertz, centered at 403.65 MHz, 
with a maximum EIRP of 100 nanowatts and with maximum duty-cycle and 
transmission session limits of 0.01% and ten per hour, respectively. 
The Commission stated that its decision was informed by the 
increasingly widespread adoption of standards internationally that 
provide for non-LBT spectrum access methods in the 402-405 MHz band. 
Furthermore, based upon the Commission's prior experience with single-
channel non-LBT devices operating under rule waivers in the core MICS 
band the Commission concluded that these EIRP and duty cycle limits 
would be sufficiently conservative to permit efficient spectrum sharing 
between LBT enabled and non-LBT devices that choose to operate at 
403.65 MHz.
    29. For devices using non-LBT spectrum access methods in the new 
MedRadio wing bands at 401-402 and 405-406 MHz, the Commission adopted 
power and duty cycle limits that match the proposals in the MedRadio 
NPRM, namely a maximum EIRP of 250 nanowatts, together with a maximum

[[Page 22700]]

duty cycle limit of 0.1% and a maximum limit of 100 communication 
sessions per hour. The Commission stated its belief that permitting the 
higher EIRP of 250 nanowatts for non-LBT operation in the wing bands, 
as compared with the 100 nanowatts adopted for non-LBT operation in the 
core band, will serve to encourage use of the wing bands for the 
majority of non-LBT applications.
    30. The Commission also recognized that some body worn devices may 
require higher power and greater bandwidth, such as the glucose 
monitoring devices manufactured by one manufacturer that are now 
operating in the core band under a waiver. Thus, the Commission decided 
to also allow non-LBT MedRadio devices using a maximum of 25 microwatts 
EIRP to operate at 401.85-402 MHz at the upper end of the lower wing 
band. The Commission determined that its decision would facilitate the 
transition of such devices now operating under waivers out of the core 
band, and into the new MedRadio wing bands. The Commission also noted 
that permitting the higher power and bandwidth would also provide 
flexibility for other manufacturers designing medical devices in these 
bands.
    31. Unwanted emissions. The Commission retained without 
modification the existing in-band and out-of-band emission limits for 
the MedRadio core band frequencies at 402-405 MHz. For the new MedRadio 
wing bands at 401-402 MHz and 405-406 MHz, the Commission adopted an 
emission mask having the same form as the emission mask that already 
exists for the core band, but modified to apply over the narrower 100 
kilohertz maximum authorized emission bandwidth of the wing band. Thus, 
the Commission required that emissions from devices operating within 
the MedRadio wing bands more than 50 kilohertz away from the center 
frequency of a transmission be attenuated below the actual transmitter 
output power by at least 20 dB. In addition, it required emissions 100 
kilohertz or less below 401 MHz, or above 406 MHz, to be attenuated 
below the maximum permitted output power by at least 20 dB. Finally, 
for out-of-band emissions at more than 100 kilohertz outside the 401 
MHz and 406 MHz MedRadio band edges, the Commission adopted generally 
the same field strength limits on emissions that presently apply to the 
core band.
    32. The Commission declined to impose more restrictive limits on 
emissions from MedRadio wing band devices into the existing core band. 
The Commission said that under such an approach, which was recommended 
by one commenter, wing band devices would be burdened with more 
stringent limits on radiation into the core band as compared to core 
band devices. The Commission found no compelling reason to place wing 
band devices on such an unequal footing with core band devices, 
particularly if such a limit were to be set below the existing general 
emission limits contained in Sec.  15.209 as suggested by one 
commenter. The Commission stated that it was confident that 
manufacturers of wing band devices are capable of designing their 
products to be compatible with and to protect core band devices, 
especially when both types of devices are used by the same patient. In 
addition, the Commission found that the emission limits it adopted 
would afford sufficient protection to satellite operations on 
frequencies below 401 MHz adjacent to the lower MedRadio wing band.
    33. RF safety and EIRP compliance. The Commission retained the 
basic requirements in the current rules as they apply RF safety and 
EIRP compliance requirements for implanted devices. In addition, the 
Commission decided that, to the extent feasible, body-worn MedRadio 
devices shall be governed by the same requirements as other hand-held 
transmitting devices for the purposes of demonstrating compliance with 
RF safety and EIRP limits.
    34. The Commission observed that it has another ongoing proceeding 
concerning RF exposure that would be better suited to address several 
other concerns expressed by some commenters. One issue involves whether 
and when open-area test sites or body-torso simulator measurements 
should be performed, and whether a 4 dB EIRP correction factor should 
be applied between implant and body-worn devices to account for the 
absorption of radio energy by body tissue that can be associated with 
implanted devices. A second issue involves whether unspecified ``other 
techniques'' (beyond the finite difference time domain (FDTD) technique 
cited in the existing rules) could be used for equipment authorization 
and RF exposure evaluation purposes. In view of the ongoing RF safety 
proceeding, the Commission declined to make any further modifications 
in this Report and Order.
    35. Disposition of Biotronik and DexCom Waivers. The Commission 
noted that it had previously granted waivers to two device 
manufacturers (Biotronik and DexCom) that permit the manufacture and 
marketing in the United States of certain models of cardiac and 
diabetic therapy devices that do not possess the LBT frequency 
monitoring capability required by the present MICS rules for the core 
band at 402-405 MHz. Both waivers were stated to be valid for one year 
from the effective date of the final MedRadio rules adopted in this 
proceeding.
    36. With respect to the Biotronik Waiver, the Commission found that 
the technical parameters of the authorized cardiac devices would now be 
encompassed within the provisions of the new MedRadio rules adopted 
herein--which provide for non-LBT operation by low power, low duty 
cycle implants operating between 403.5-403.8 MHz in the 402-405 MHz 
core band. Consequently, the Commission found that Biotronik Waiver 
would be rendered moot upon the effective date of the MedRadio rules 
adopted in this Report and Order.
    37. With respect to the DexCom Waiver, the Commission found that 
the covered devices did not comply with the new MedRadio rules. It thus 
decided to extend the waiver term for four years from the effective 
date of the MedRadio rules adopted herein. The Commission stated that 
this extended term should provide DexCom with sufficient time to come 
into compliance with the new MedRadio rules and to obtain the required 
FDA approval. The Commission also found that continued operation of the 
DexCom non-LBT devices in the core band, particularly at the higher 
power levels they use, could in the long term prove problematic for 
other rules-compliant devices--especially those used for life-critical 
applications--as the numbers of these types of devices grow. Further, 
the Commission also observed that the wing bands provide adequate 
spectrum for both LBT and non-LBT body-worn devices and that DexCom's 
devices may reasonably be accommodated under the new MedRadio rules for 
these bands. In declining to extend the waiver for 5 years as requested 
by DexCom, the Commission stated that it was not persuaded that the 
relatively small move in operating frequency, while maintaining 
emission bandwidth, power and duty cycle specifications, would require 
5 additional years. Thus, the Commission encouraged DexCom to 
transition to the newly designated spectrum as soon as practicable.

[[Page 22701]]

Final Regulatory Flexibility Analysis

    38. As required by the Regulatory Flexibility Act (RFA),\1\ an 
Initial Regulatory Flexibility Analysis (IFRA) was incorporated in the 
Notice of Proposed Rulemaking and Notice of Inquiry and Order (MedRadio 
NPRM) in ET Docket No. 06-135.\2\ The Commission sought written public 
comment on the proposals in the MedRadio NPRM, including comment on the 
IRFA. This present Final Regulatory Flexibility Analysis (FRFA) 
conforms to the RFA.
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    \1\ 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 
1966 (SBREFA), Public Law 104-121, Title II, 110 Stat. 857 (1996).
    \2\ 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, ET Docket No. 06-135, 
RM-11271, Notice of Proposed Rulemaking and Notice of Inquiry and 
Order, 21 FCC Rcd 8164 (2006).
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A. Need for and Objectives, of the Report and Order

    39. The Report and Order establishes the Medical Device 
Radiocommunication Service (MedRadio) under part 95 of the Commission's 
rules. This new service will incorporate the existing Medical Implant 
Communications Service (MICS) ``core'' band at 402-405 MHz, and include 
two megahertz of newly designated spectrum in the adjacent ``wing'' 
bands at 401-402 MHz and 405-406 MHz. Altogether, the MedRadio Service 
will provide a total of five megahertz of contiguous spectrum for 
advanced wireless medical radiocommunication devices to be used for 
diagnostic and therapeutic purposes in humans. Among other benefits, 
the MedRadio Service will accommodate the operation of body-worn as 
well as implanted medical devices, including those using either LBT or 
non-LBT spectrum access methods, in designated portions of the 401-406 
MHz band.
    40. Significant advances in wireless implanted and body-worn 
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. As 
demonstrated by the comment record in this proceeding, implanted and 
body-worn medical devices that rely upon wireless technologies are 
being used even today to treat a variety of cardiac and diabetic 
conditions. For example, wireless implanted cardiac devices serve as 
defibrillators and pacemakers without the need for external wired 
connections; while other radio-equipped devices, such as blood glucose 
monitors and insulin pumps, support more timely treatment for diabetic 
patients and allow physicians to wirelessly retrieve data and then make 
operating parameter adjustments with greater ease and accuracy than 
with the more traditional wired connection technologies. Some examples 
of newer generations of devices that could benefit from the use of 
wireless technologies include implanted vagus nerve stimulators that 
send electric pulses to the brain to treat severe chronic depression, 
and deep brain stimulators used to treat tremors related to Parkinson's 
disease.\3\ Such advances have the potential to significantly improve 
the quality of life and sophistication of therapy for countless 
Americans living with a variety of medical conditions; and, in turn, 
could result in lower medical costs and extend the time between 
hospital visits and surgical procedures.
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    \3\ Id.
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B. Summary of Significant Issues Raised by Public Comments in Response 
to the IRFA

    41. There were no comments filed that specifically addressed the 
rules and policies proposed in the IFRA.

C. Description and Estimate of the Number of Small Entities to Which 
the Rules Will Apply

    42. 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.\4\ The RFA generally 
defines the term ``small entity'' as having the same meaning as the 
terms ``small business,'' ``small organization,'' and ``small 
governmental jurisdiction.'' \5\ In addition, the term ``small 
business'' has the same meaning as the term ``small business concern'' 
under the Small Business Act.\6\ 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.\7\
---------------------------------------------------------------------------

    \4\ 5 U.S.C. 603(b)(3).
    \5\ 5 U.S.C. 601(6).
    \6\ 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).
    \7\ Small Business Act, 15 U.S.C. 632 (1996).
---------------------------------------------------------------------------

    43. Nationwide, there are a total of approximately 22.4 million 
small businesses, according to SBA data.\8\ A ``small organization'' is 
generally ``any not-for-profit enterprise which is independently owned 
and operated and is not dominant in its field.'' \9\ Nationwide, as of 
2002, there were approximately 1.6 million small organizations.\10\ 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.'' 
\11\ Census Bureau data for 2002 indicate that there were 87,525 local 
governmental jurisdictions in the United States.\12\ We estimate that, 
of this total, 84,377 entities were ``small governmental 
jurisdictions.'' \13\ Thus, we estimate that most governmental 
jurisdictions are small.
---------------------------------------------------------------------------

    \8\ See SBA, Programs and Services, SBA Pamphlet No. CO-0028, at 
page 40 (July 2002).
    \9\ 5 U.S.C. 601(4).
    \10\ Independent Sector, The New Nonprofit Almanac & Desk 
Reference (2002).
    \11\ 5 U.S.C. 601(5).
    \12\ U.S. Census Bureau, Statistical Abstract of the United 
States: 2006, Section 8, page 272, Table 415.
    \13\ 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.
---------------------------------------------------------------------------

    44. Personal Radio Services. The Medical Device Radio 
Communications Service are being placed 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 and covers a broad range of uses.\14\ Many of the licensees in 
these services are individuals, and thus are not small entities. In 
addition, due to the fact that licensing of operation under part 95 is 
accomplished by rule (rather than by issuance of individual license), 
and due to the shared nature of the spectrum utilized by some 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

[[Page 22702]]

definition that might be directly affected by the proposed rules.
---------------------------------------------------------------------------

    \14\ 47 CFR part 90.
---------------------------------------------------------------------------

    45. The Commission notes, however, that the designation for the two 
megahertz of spectrum for the Medical Device Radio Communications 
Service would be limited to use by medical implant and body-worn 
medical devices and, thus, would not be shared with other non-Federal 
Governmental uses. To date, there are only a small number of 
manufacturers (i.e., less than ten--as few as five) that produce these 
devices, and FDA approval must be secured before such devices are 
brought to market. Due to the stringent FDA approval requirements, the 
small number of existing medical device manufacturers tends to focus 
very narrowly on this highly specialized market niche.
    46. Wireless Communications Equipment Manufacturers. The Census 
Bureau does not have a category specific to medical device 
radiocommunication manufacturing. The appropriate category is that for 
wireless communications equipment manufacturers. The Census Bureau 
defines this category as follows: ``This industry comprises 
establishments primarily engaged in manufacturing radio and television 
broadcast and wireless communications equipment. Examples of products 
made by these establishments are: transmitting and receiving antennas, 
cable television equipment, GPS equipment, pagers, cellular phones, 
mobile communications equipment, and radio and television studio and 
broadcasting equipment.'' The SBA has developed a small business size 
standard for Radio and Television Broadcasting and Wireless 
Communications Equipment Manufacturing, which is: all such firms having 
750 or fewer employees.\15\ According to Census Bureau data for 2002, 
there were a total of 1,041 establishments in this category that 
operated for the entire year. Of this total, 1,010 had employment of 
under 500, and an additional 13 had employment of 500 to 999. Thus, 
under this size standard, the majority of firms can be considered 
small.\16\
---------------------------------------------------------------------------

    \15\ NAICS code 334220.
    \16\ NAICS code 11210.
---------------------------------------------------------------------------

    47. Wireless Service Providers. The SBA has developed a small 
business size standard for wireless firms within the two broad economic 
census categories of ``Paging'' \17\ and ``Cellular and Other Wireless 
Telecommunications.'' \18\ 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. \19\ Of this total, 804 firms had employment of 999 or fewer 
employees, and three firms had employment of 1,000 employees or 
more.\20\ 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.\21\ Of this total, 1,378 firms had 
employment of 999 or fewer employees, and 19 firms had employment of 
1,000 employees or more.\22\ Thus, under this second category and size 
standard, the majority of firms can, again, be considered small.
---------------------------------------------------------------------------

    \17\ 13 CFR 121.201, NAICS code 517211.
    \18\ 13 CFR 121.201, NAICS code 517212.
    \19\ 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).
    \20\ 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.''
    \21\ 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).
    \22\ 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.''
---------------------------------------------------------------------------

    48. Public Safety Radio Services. Public Safety radio services 
include police, fire, local government, forestry conservation, highway 
maintenance, and emergency medical services.\23\ 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 \24\ 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.\25\
---------------------------------------------------------------------------

    \23\ With the exception of the special emergency service, these 
services are governed by Subpart B of part 90 of the Commission's 
Rules, 47 CFR 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 90.15-90.27. 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 90.33-90.55.
    \24\ 47 CFR 1.1162.
    \25\ 5 U.S.C. 601(5).
---------------------------------------------------------------------------

D. Description of Projected Reporting, Recordkeeping, and Other 
Compliance Requirements for Small Entities

    49. The Commission is using the licensing approach for the entire 
401-406 MHz MedRadio band that is identical to that used for the 
existing MICS band at 402-405 MHz. Thus, rather than require individual 
transmitter licensing, the Commission authorizes 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.\26\ Licensing 
will be accomplished through adherence to applicable technical 
standards and other operating rules (unlicensed operations). The 
Commission concludes that this approach is beneficial because it would 
minimize the administrative burden on prospective licensees as compared 
with an individual licensing scheme.
---------------------------------------------------------------------------

    \26\ See Medtronic Petition at i, 16, and Appendix A, at 
proposed Sec.  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.
---------------------------------------------------------------------------

E. Steps Taken To Minimize the Significant Economic Impact on Small 
Entities, and Significant Alternatives Considered

    50. 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

[[Page 22703]]

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.\27\
---------------------------------------------------------------------------

    \27\ See 5 U.S.C. 603(c).
---------------------------------------------------------------------------

    51. In the Report and Order the Commission established a new 
Medical Device Radiocommunication Service (MedRadio Service) under part 
95, which will encompass all medical devices permitted to operate in 
the 401-406 MHz band. It sought comment on the options concerning 
whether and how the five megahertz of spectrum that would comprise this 
MedRadio band could be divided among the evolving varieties of both 
implanted and body-worn medical transmitters, including low-power, low-
duty-cycle (LPLDC) devices that do not employ ``listen-before-talk'' 
(LBT) frequency monitoring spectrum access techniques.
    52. Report to Congress: The Commission will send a copy of the 
Report and Order, including this FRFA, in a report to be sent to 
Congress pursuant to the Congressional Review Act.\28\ In addition, the 
Commission will send a copy of the Report and Order, including this 
FRFA, to the Chief Counsel for Advocacy of the SBA.
---------------------------------------------------------------------------

    \28\ See 5 U.S.C. 801(a)(1)(A).
---------------------------------------------------------------------------

Ordering Clauses

    53. Pursuant to the authority contained in Sections 4(i), 301, 302, 
303(e), 303(f) and 303(r) of the Communications Act of 1934, as 
amended, 47 USC Sections 154(i), 301, 302, 303(e), 303(f) and 303(r), 
this Report and Order is adopted and parts 1, 2 and 95 of the 
Commission's Rules are amended as set forth in Final Rules effective 90 
days after publication in the Federal Register.
    54. The Commission grants in part, consistent with the terms of 
this order, DexCom, Inc.'s request for extension of waiver, and 
otherwise deny the request in all other respects.
    55. ET Docket No. 03-92 is terminated.
    56. The Commission's Consumer and Governmental Affairs Bureau, 
Reference Information Center, shall send a copy of this Report and 
Order, including the Final Regulatory Flexibility Analysis in Appendix 
C, to the Chief Counsel for Advocacy of the Small Business 
Administration.

List of Subjects

47 CFR Part 1

    Administrative practice and procedure.

47 CFR Parts 2 and 95

    Communications equipment, Radio, Reporting and recordkeeping 
requirements.

Federal Communications Commission.
Marlene H. Dortch,
Secretary.

Final Rules

0
For the reasons discussed in the preamble, the Federal Communications 
Commission amends 47 CFR parts 1, 2, and 95 to read as follows:

PART 1--PRACTICE AND PROCEDURE

0
1. The authority citation for part 1 continues to read as follows:

    Authority: 15 U.S.C. 79 et seq.; 47 U.S.C. 151, 154(i), 154(j), 
155, 157, 225, 303(r), and 309.


0
2. Section 1.1307 is amended by revising the fourth sentence in 
paragraph (b)(2) to read as follows:


Sec.  1.1307  Actions that may have a significant environmental effect, 
for which Environmental Assessments (EAs) must be prepared.

* * * * *
    (b) * * *
    (2) * * * Equipment authorized for use in the Medical Device 
Radiocommunication Service (MedRadio) as a medical implant or body-worn 
transmitter (as defined in Appendix 1 to Subpart E of part 95 of this 
chapter) is subject to routine environmental evaluation for RF exposure 
prior to equipment authorization, as specified in Sec.  2.1093 of this 
chapter by finite difference time domain computational modeling or 
laboratory measurement techniques. * * *
* * * * *

PART 2--FREQUENCY ALLOCATIONS AND RADIO TREATY MATTERS; GENERAL 
RULES AND REGULATIONS

0
3. The authority citation for part 2 continues to read as follows:

    Authority: 47 U.S.C. 154, 302a, 303, and 336, unless otherwise 
noted.


0
4. Section 2.106, the Table of Frequency Allocations, is amended as 
follows:
0
a. Revise page 24.
0
b. In the list of United States (US) footnotes, revise footnote US345.
    The revisions read as follows:


Sec.  2.106  Table of Frequency Allocations.

* * * * *
BILLING CODE 6712-01-P

[[Page 22704]]

[GRAPHIC] [TIFF OMITTED] TR14MY09.000

BILLING CODE 6712-01-C
* * * * *

United States (US) Footnotes

* * * * *
    US345 In the band 401-406 MHz, the mobile, except aeronautical 
mobile, service is allocated on a secondary basis and is limited to, 
with the exception of military tactical mobile stations, Medical Device 
Radiocommunication Service (MedRadio) operations. MedRadio stations are 
authorized by rule on the condition that harmful interference is not 
caused to stations in the meteorological aids, meteorological-
satellite, and Earth exploration-satellite services, and that MedRadio 
stations accept interference from stations in the meteorological aids, 
meteorological-satellite, and Earth exploration-satellite services.
* * * * *

0
5. Section 2.1093 is amended by revising paragraph (c) to read as 
follows:


Sec.  2.1093  Radiofrequency radiation exposure evaluation: portable 
devices.

* * * * *
    (c) Portable devices that operate in the Cellular Radiotelephone 
Service, the Personal Communications Service (PCS), the Satellite 
Communications Services, the General Wireless Communications Service, 
the Wireless Communications Service, the Maritime Services, the 
Specialized Mobile Radio Service, the 4.9 GHz Band Service, the 
Wireless Medical Telemetry Service (WMTS) and the Medical Device 
Radiocommunication Service (MedRadio), authorized under subpart H of 
part 22 of this chapter, parts 24, 25, 26, 27, 80 and 90 of this 
chapter, subparts H and I of part 95 of this chapter, and unlicensed 
personal communication service, unlicensed NII devices and millimeter 
wave devices authorized under subparts D and E, 15.253, 15.255 and 
15.257 of this chapter are subject to routine environmental evaluation 
for RF exposure prior to equipment authorization or use. All other 
portable transmitting devices are categorically excluded from routine 
environmental evaluation for RF exposure prior to equipment 
authorization or use, except as specified in 1.1307(c) and 1.1307(d) of 
this chapter. Applications for equipment authorization of portable 
transmitting devices subject to routine environmental evaluation must 
contain a statement confirming compliance with the limits specified in 
paragraph (d) of this section as part of their application. Technical 
information showing the basis for this statement must be submitted to 
the Commission upon request.
* * * * *

0
6. Section 2.1204 is amended by revising paragraph (a)(9) to read as 
follows:


Sec.  2.1204  Import conditions.

    (a) * * *
* * * * *
    (9) The radio frequency device is a medical implant transmitter 
inserted in a person or a medical body-worn transmitter as defined in 
part 95, granted entry into the United States or is a control 
transmitter associated with such an implanted or body-worn transmitter, 
provided, however that the transmitters covered by this provision 
otherwise comply with the technical requirements applicable to 
transmitters

[[Page 22705]]

authorized to operate in the Medical Device Radiocommunication Service 
(MedRadio) under part 95 of this chapter. Such transmitters are 
permitted to be imported without the issuance of a grant of equipment 
authorization only for the personal use of the person in whom the 
medical implant transmitter has been inserted or on whom the medical 
body-worn transmitter is applied.
* * * * *

PART 95--PERSONAL RADIO SERVICES

0
7. The authority citation for part 95 continues to read as follows:

    Authority: Sections 4, 303, 48 Stat. 1066, 1082, as amended; 47 
U.S.C. 154, 303.


0
8. Section 95.401 is amended by revising paragraph (d) to read as 
follows:


Sec.  95.401  (CB Rule 1) What are the Citizens Band Radio Services?

* * * * *
    (d) The Medical Device Radiocommunication Service (MedRadio)--an 
ultra-low power radio service, for the transmission of non-voice data 
for the purpose of facilitating diagnostic and/or therapeutic functions 
involving implanted and body-worn medical devices. The rules for this 
service are contained in subpart I of this part.
* * * * *

0
9. Section 95.601 is amended by revising the last sentence to read as 
follows:


Sec.  95.601  Basis and purpose.

    * * * The Personal Radio Services are the GMRS (General Mobile 
Radio Service)--subpart A, the Family Radio Service (FRS)--subpart B, 
the R/C (Radio Control Radio Service)--subpart C, the CB (Citizens Band 
Radio Service)--subpart D, the Low Power Radio Service (LPRS)--subpart 
G, the Wireless Medical Telemetry Service (WMTS)--subpart H, the 
Medical Device Radiocommunication Service (MedRadio)--subpart I, the 
Multi-Use Radio Service (MURS)--subpart J, and Dedicated Short-Range 
Communications Service On-Board Units (DSRCS-OBUs)--subpart L.

0
10. Section 95.603 is amended by revising paragraph (f) to read as 
follows:


Sec.  95.603  Certification required.

* * * * *
    (f) Each Medical Device Radiocommunication Service (MedRadio) 
transmitter (a transmitter that operates or is intended to operate in 
the MedRadio service) must be certificated except for such transmitters 
that are not marketed for use in the United States, but which otherwise 
comply with the MedRadio Service technical requirements and are 
operated in the United States by individuals who have traveled to the 
United States from abroad.
* * * * *

0
11. Section 95.605 is revised to read as follows:


Sec.  95.605  Certification procedures.

    Any entity may request certification for its transmitter when the 
transmitter is used in the GMRS, FRS, R/C, CB, 218-219 MHz Service, 
LPRS, MURS, or MedRadio Service following the procedures in part 2 of 
this chapter. Dedicated Short-Range Communications Service On-Board 
Units (DSRCS-OBUs) must be certified in accordance with subpart L of 
this part and subpart J of part 2 of this chapter.

0
12. Section 95.628 is revised to read as follows:


Sec.  95.628  MedRadio transmitters.

    (a) Frequency monitoring. Except as provided in (b) of this 
section, all MedRadio programmer/control transmitters operating in the 
401-406 MHz band must operate under the control of a monitoring system 
that incorporates a mechanism for monitoring the channel or channels 
that the MedRadio system devices intend to occupy. The monitoring 
system antenna shall be the antenna normally used by the programmer/
control transmitter for a communications session. Before the monitoring 
system of a MedRadio programmer/control transmitter initiates a 
MedRadio communications session, the following access criteria must be 
met:
    (1) The monitoring system bandwidth measured at its 20 dB down 
points must be equal to or greater than the emission bandwidth of the 
intended transmission.
    (2) Within 5 seconds prior to initiating a communications session, 
circuitry associated with a MedRadio programmer/control transmitter 
must monitor the channel or channels the system devices intend to 
occupy for a minimum of 10 milliseconds per channel.
    (3) Based on use of an isotropic monitoring system antenna, the 
monitoring threshold power level must not be more than 10logB(Hz) -150 
(dBm/Hz) + G(dBi), where B is the emission bandwidth of the MedRadio 
communications session transmitter having the widest emission and G is 
the MedRadio programmer/control transmitter monitoring system antenna 
gain relative to an isotropic antenna. For purposes of showing 
compliance with the above provision, the above calculated threshold 
power level must be increased or decreased by an amount equal to the 
monitoring system antenna gain above or below the gain of an isotropic 
antenna, respectively.
    (4) If no signal in a MedRadio channel above the monitoring 
threshold power level is detected, the MedRadio programmer/control 
transmitter may initiate a MedRadio communications session involving 
transmissions to and from a medical implant or medical body-worn device 
on that channel. The MedRadio communications session may continue as 
long as any silent period between consecutive data transmission bursts 
does not exceed 5 seconds. If a channel meeting the criteria in 
paragraph (a)(3) of this section is unavailable, the channel with the 
lowest ambient power level may be accessed.
    (5) When a channel is selected prior to a MedRadio communications 
session, it is permissible to select an alternate channel for use if 
communications are interrupted, provided that the alternate channel 
selected is the next best choice using the above criteria. The 
alternate channel may be accessed in the event a communications session 
is interrupted by interference. The following criteria must be met:
    (i) Before transmitting on the alternate channel, the channel must 
be monitored for a period of at least 10 milliseconds.
    (ii) The detected power level during this 10 millisecond or greater 
monitoring period must be no higher than 6dB above the power level 
detected when the channel was chosen as the alternate channel.
    (iii) In the event that this alternate channel provision is not 
used by the MedRadio system or if the criteria in paragraphs (a)(5)(i) 
and (ii) are not met, a channel must be selected using the access 
criteria specified in paragraphs (a)(1) through (a)(4) of this section.
    (6) As used in this section, the following definitions apply:
    (i) Emission bandwidth-- Measured as the width of the signal 
between the points on either side of carrier center frequency that are 
20 dB down relative to the maximum level of the modulated carrier. 
Compliance will be determined using instrumentation employing a peak 
detector function and a resolution bandwidth approximately equal to 1% 
of the emission bandwidth of the device under test.
    (ii) MedRadio channel--Any continuous segment of spectrum in the 
MedRadio band that is equal to the

[[Page 22706]]

emission bandwidth of the device with the largest bandwidth that is to 
participate in a MedRadio communications session.
    Note to paragraph (a)(6)(ii): The rules do not specify a channeling 
scheme for use by MedRadio systems.
    (iii) MedRadio communications session--A collection of 
transmissions, that may or may not be continuous, between MedRadio 
system devices.
    (b) Exceptions to frequency monitoring criteria. MedRadio devices 
or communications sessions that meet any one of the following criteria 
are not required to use the access criteria set forth in paragraph (a) 
of this section:
    (1) MedRadio communications sessions initiated by a medical implant 
event.
    (2) MedRadio devices operating in either the 401-401.85 MHz or 405-
406 MHz bands, provided that the transmit power is not greater than 250 
nanowatts EIRP and the duty cycle for such transmissions does not 
exceed 0.1%, based on the total transmission time during a one-hour 
interval.
    (3) MedRadio devices operating in the 401.85-402 MHz band, provided 
that the transmit power is not greater than 25 microwatts EIRP and the 
duty cycle for such transmissions does not exceed 0.1%, based on the