[Federal Register: May 14, 2009 (Volume 74, Number 92)]
[Rules and Regulations]
[Page 22696-22710]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my09-12]
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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
http://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\
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\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.
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\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.
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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\
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\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).
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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
total transmission time during a one-hour interval.
(4) MedRadio devices operating with a total emission bandwidth not
exceeding 300 kHz centered at 403.65 MHz, provided that the transmit
power is not greater than 100 nanowatts EIRP and the duty cycle for
such transmissions does not exceed 0.01%, based on the total
transmission time during a one-hour interval.
(c) Operating frequency. MedRadio stations authorized under this
part may operate on frequencies in the 401-406 MHz band as follows
provided that the out-of-band emissions are attenuated in accordance
with Sec. 95.635:
(1) MedRadio stations associated with medical implant devices,
which incorporate a frequency monitoring system as set forth in
paragraph (a) of this section, may operate on any of the frequencies in
the 401-406 MHz band.
(2) MedRadio stations associated with medical implant devices,
which do not incorporate a frequency monitoring system as set forth in
paragraph (a) of this section, may operate on any frequency in 401-402
MHz or 405-406 MHz bands, or at 403.65 MHz in the 402-405 MHz band.
(3) MedRadio stations associated with medical body-worn devices,
regardless of whether a frequency monitoring system as set forth in
paragraph (a) of this section is employed, may operate on any of the
frequencies in the 401-402 MHz or 405-406 MHz bands.
(4) MedRadio stations that are used externally to evaluate the
efficacy of a more permanent medical implant device, regardless of
whether a frequency monitoring system as set forth in paragraph (a) of
this section is employed, may operate on any of the frequencies in the
402-405 MHz band, provided that:
(i) Such external body-worn 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;
(ii) 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;
(iii) The maximum output power of the temporary body-worn device
shall not exceed 200 nW EIRP; and
(iv) The temporary body-worn device must comply fully with all
other MedRadio rules applicable to medical implant device operation in
the 402-405 MHz band.
(d) Authorized bandwidth. The authorized bandwidth of the emission
from a MedRadio station operating between 402-405 MHz shall not exceed
300 kHz, and no communications session involving MedRadio stations
shall use more than a total of 300 kHz of bandwidth during such a
session. The authorized bandwidth of the emission from a MedRadio
station operating between 401-401.85 MHz or 405-406 MHz shall not
exceed 100 kHz, and no communications session involving MedRadio
stations shall use more than a total of 100 kHz of bandwidth during
such a session. The authorized bandwidth of the emission from a
MedRadio station operating between 401.85-402 MHz shall not exceed 150
kHz, and no communications session involving MedRadio stations shall
use more than a total of 150 kHz of bandwidth during such a session.
Note to paragraph (d): This provision does not preclude full duplex
or half duplex communications provided that the total amount of
bandwidth utilized by all of the MedRadio channels employed in such a
MedRadio communications session does not exceed 300 kHz in the 402-405
MHz band, or 100 kHz in the 401-402 MHz and 405-406 MHz bands.
(e) Frequency stability. Each transmitter in the MedRadio service
must maintain a frequency stability of 100 ppm of the
operating frequency over the range:
(1) 25[deg] C to 45[deg] C in the case of medical implant
transmitters; and
(2) 0[deg] C to 55[deg] C in the case of MedRadio programmer/
control transmitters and MedRadio body-worn transmitters.
(f) Shared access. The provisions of this section shall not be used
to extend the range of spectrum occupied over space or time for the
purpose of denying fair access to spectrum for other MedRadio systems.
(g) Measurement procedures. (1) MedRadio transmitters shall be
tested for frequency stability, radiated emissions and EIRP limit
compliance in accordance with paragraphs (g)(2) and (g)(3) of this
section.
(2) Frequency stability testing shall be performed over the
temperature range set forth in (e) of this section.
(3) Radiated emissions and EIRP limit measurements limit may be
determined by measuring the radiated field from the equipment under
test at 3 meters and calculating the EIRP. The equivalent radiated
field strength at 3 meters for 25 microwatts, 250 nanowatts, and 100
nanowatts EIRP is 18.2, 1.8, or 1.2 mV/meter, respectively, when
measured on an open area test site; or 9.1, 0.9, or 0.6 mV/meter,
respectively, when measured on a test site equivalent to free space
such as a fully anechoic test chamber. Power measurements for
transmissions by stations authorized under this section may be made
either in accordance with a Commission-approved peak power technique,
or the following. Peak transmit power must be measured over any
interval of continuous transmission using instrumentation calibrated in
terms of an rms-equivalent voltage. The measurement results shall be
properly adjusted for any instrument limitations, such as detector
response times, limited resolution bandwidth capability when compared
to the emission bandwidth, sensitivity, etc., so as to obtain a true
peak measurement for the emission in question over the full bandwidth
of the channel.
(i) For a transmitter intended to be implanted in a human body,
radiated emissions and EIRP measurements for transmissions by stations
authorized under this section may be made in accordance with a
Commission-approved human body simulator and test technique. A formula
for a suitable tissue substitute material is defined in OET Bulletin 65
Supplement C (01-01).
0
13. Section 95.631 is amended by revising paragraph (h) to read as
follows:
[[Page 22707]]
Sec. 95.631 Emission types.
* * * * *
(h) A MedRadio station may transmit any emission type appropriate
for communications in this service. Voice communications, however, are
prohibited.
* * * * *
0
14. Section 95.633 is amended by revising paragraph (e) to read as
follows:
Sec. 95.633 Emission bandwidth.
* * * * *
(e) For transmitters in the MedRadio Service:
(1) For stations operating in 402-405 MHz, the maximum authorized
emission bandwidth is 300 kHz. For stations operating in 401-401.85 MHz
or 405-406 MHz, the maximum authorized emission bandwidth is 100 kHz,
and stations operating in 401.85-402 MHz, the maximum authorized
emission bandwidth is 150 kHz.
(2) Lesser emission bandwidths may be employed, provided that the
unwanted emissions are attenuated as provided in Sec. 95.635. See
Sec. Sec. 95.628(g) and 95.639(f) regarding maximum transmitter power
and measurement procedures.
(3) Emission bandwidth will be determined by measuring the width of
the signal between points, one below the carrier center frequency and
one above the carrier center frequency, that are 20 dB down relative to
the maximum level of the modulated carrier. Compliance with the
emission bandwidth limit is based on the use of measurement
instrumentation employing a peak detector function with an instrument
resolution bandwidth approximately equal to 1.0 percent of the emission
bandwidth of the device under measurement.
* * * * *
0
15. Section 95.635 is amended by revising the table to paragraph (b),
and by revising paragraph (d) to read as follows:
Sec. 95.635 Unwanted radiation.
* * * * *
(b) * * *
------------------------------------------------------------------------
Applicable
Transmitter Emission type paragraphs (b)
------------------------------------------------------------------------
GMRS.......................... A1D, A3E, F1D, G1D, (1), (3), (7).
F3E, G3E with
filtering.
A1D, A3E, F1D, G1D, (5), (6), (7).
F3E, G3E without
filtering.
H1D, J1D, R1D, H3E, (2), (4), (7).
J3E, R3E.
FRS........................... F3E with filtering.... (1), (3), (7).
R/C: ................
27 MHz.................... As specified in Sec. (1), (3), (7).
95.631(b).
72-76 MHz................. As specified in Sec. (1), (3), (7),
95.631(b). (10), (11),
(12).
CB............................ A1D, A3E.............. (1), (3), (8),
(9).
H1D, J1D, R1D, H3E, (2), (4), (8),
J3E, R3E. (9).
A1D, A3E type accepted (1), (3), (7).
before September 10,
1976.
H1D, J1D, R1D, H3E, (2), (4), (7).
J3E, R3E type
accepted before
September 10, 1986.
LPRS.......................... As specified in ................
paragraph (c).
MedRadio...................... As specified in ................
paragraph (d).
DSRCS-OBU..................... As specified in ................
paragraph (f) of this
section.
------------------------------------------------------------------------
* * * * *
(d) For transmitters designed to operate in the MedRadio service,
emissions shall be attenuated in accordance with the following:
(paragraphs (d)(1) through (d)(5) pertain to MedRadio transmitters
operating in the 402-405 MHz band; paragraphs (d)(6) through (d)(10)
pertain to MedRadio transmitters operating in the 401-402 MHz or 405-
406 MHz bands).
(1) Emissions from a MedRadio transmitter more than 250 kHz outside
of the 402-405 MHz band shall be attenuated to a level no greater than
the following field strength limits:
------------------------------------------------------------------------
Field strength Measurement
Frequency (MHz) ([mu]V/m) distance (m)
------------------------------------------------------------------------
30-88............................. 100 3
88-216............................ 150 3
216-960........................... 200 3
960 and above..................... 500 3
------------------------------------------------------------------------
Note--At band edges, the tighter limit applies.
(2) The emission limits shown in the table of paragraph (d)(1) are
based on measurements employing a CISPR quasi-peak detector except that
above 1 GHz, the limit is based on measurements employing an average
detector. Measurements above 1 GHz shall be performed using a minimum
resolution bandwidth of 1 MHz. See also Sec. 95.605.
(3) The emissions from a MedRadio transmitter must be measured to
at least the tenth harmonic of the highest fundamental frequency
designed to be emitted by the transmitter.
(4) Emissions within the 402-405 MHz band more than 150 kHz away
from the center frequency of the spectrum the transmission is intended
to occupy will be attenuated below the transmitter output power by at
least 20 dB. Compliance with this limit is based on the use of
measurement instrumentation employing a peak detector function with an
instrument resolution bandwidth approximately equal to 1.0 percent of
the emission bandwidth of the device under measurement.
(5) Emissions 250 kHz or less that are above or below the 402-405
MHz band will be attenuated below the maximum permitted output power by
at least 20 dB. Compliance with this limit is based on the use of
measurement instrumentation employing a peak
[[Page 22708]]
detector function with an instrument resolution bandwidth approximately
equal to 1.0 percent of the emission bandwidth of the device under
measurement.
(6) Emissions from a MedRadio transmitter operating in the 401-402
MHz or 405-406 MHz bands that are more than 100 kHz outside of either
the 401-402 MHz or 405-406 MHz bands, and all emissions from such
transmitter in the band 406.000-406.100 MHz shall be attenuated to a
level no greater than the following field strength limits:
------------------------------------------------------------------------
Field strength Measurement
Frequency (MHz) ([mu]V/m) distance (m)
------------------------------------------------------------------------
30-88............................. 100 3
88-216............................ 150 3
216-960........................... 200 3
960 and above..................... 500 3
------------------------------------------------------------------------
Note--At band edges, the tighter limit applies.
(7) The emission limits shown in paragraph (d)(6) are based on
measurements employing a CISPR quasi-peak detector except that above 1
GHz, the limit is based on measurements employing an average detector.
Measurements above 1 GHz shall be performed using a minimum resolution
bandwidth of 1 MHz. See also Sec. 95.605.
(8) The emissions from a MedRadio transmitter operating in the
MedRadio bands (between 401-402 MHz or 405-406 MHz) must be measured to
at least the tenth harmonic of the highest fundamental frequency
designed to be emitted by the transmitter.
(9) Emissions between 401-401.85 MHz or 405-406 MHz within the
MedRadio bands that are more than 50 kHz away from the center frequency
of the spectrum the transmission is intended to occupy (or more than 75
kHz away from the center frequency of MedRadio transmitters operating
between 401.85-402 MHz) shall be attenuated below the transmitter
output power by at least 20 dB. Compliance with this limit is based on
the use of measurement instrumentation employing a peak detector
function with an instrument resolution bandwidth approximately equal to
1.0 percent of the emission bandwidth of the device under measurement.
(10) Emissions 100 kHz or less below 401 MHz or above 406 MHz shall
be attenuated below the maximum permitted output power by at least 20
dB. Compliance with this limit is based on the use of measurement
instrumentation employing a peak detector function with an instrument
resolution bandwidth approximately equal to 1.0 percent of the emission
bandwidth of the device under measurement.
* * * * *
0
16. Section 95.639 is amended by revising paragraph (f) to read as
follows:
Sec. 95.639 Maximum transmitter power.
* * * * *
(f) In the MedRadio Service for transmitters that are not excepted
under Sec. 95.628(b) from the frequency monitoring requirements of
Sec. 95.628(a), the maximum radiated power in any 300 kHz bandwidth by
MedRadio transmitters operating at 402-405 MHz, or in any 100 kHz
bandwidth by MedRadio transmitters operating at 401-402 MHz or 405-406
MHz shall not exceed 25 microwatts EIRP. For transmitters that are
excepted under Sec. 95.628(b) from the frequency monitoring
requirements of Sec. 95.628(a), the power radiated by any station
operating in 402-405 MHz shall not exceed 100 nanowatts EIRP confined
to a maximum total emission bandwidth of 300 kHz centered at 403.65
MHz. For transmitters that are excepted under Sec. 95.628(b) from the
frequency monitoring requirements of Sec. 95.628(a), the power
radiated by any station operating in 401-401.85 MHz or 405-406 MHz
shall not exceed 250 nanowatts EIRP in any 100 kHz bandwidth and in
401.85-402 MHz shall not exceed 25 microwatts in the 150 kHz bandwidth.
See Sec. Sec. 95.633(e). The antenna associated with any MedRadio
transmitter must be supplied with the transmitter and shall be
considered part of the transmitter subject to equipment authorization.
Compliance with these EIRP limits may be determined as set forth in
Sec. 95.628(g).
* * * * *
0
17. Section 95.649 is revised to read as follows:
Sec. 95.649 Power capability.
No CB, R/C, LPRS, FRS, MedRadio, MURS, or WMTS unit shall
incorporate provisions for increasing its transmitter power to any
level in excess of the limits specified in Sec. 95.639.
0
18. Section 95.651 is revised to read as follows:
Sec. 95.651 Crystal control required.
All transmitters used in the Personal Radio Services must be
crystal controlled, except an R/C station that transmits in the 26-27
MHz frequency band, a FRS unit, a LPRS unit, a MURS unit, a MedRadio
transmitter, or a WMTS unit.
0
19. Appendix 1 to Subpart E of Part 95--Glossary of Terms is amended by
removing the definition of ``Medical Implant Communications Service
(MICS) transmitter'', ``MICS programmer/control transmitter'' and
``MICS''; and by revising the definitions of ``EIRP'', ``Medical
implant transmitter''; and by adding the definitions of ``Medical body-
worn device'', ``Medical body-worn transmitter'', ``MedRadio
programmer/control transmitter'', ``MedRadio Service'' and ``MedRadio
transmitter'' in alphabetical order to read as follows:
APPENDIX 1 TO SUBPART E OF PART 95--GLOSSARY OF TERMS
* * * * *
EIRP. Effective Isotropic Radiated Power. Antenna input power
times gain for free-space or in-tissue measurement configurations
required by MedRadio, expressed in watts, where the gain is
referenced to an isotropic radiator.
* * * * *
Medical body-worn device. Apparatus that is placed on or in
close proximity to the human body (e.g., within a few centimeters)
for the purpose of performing diagnostic or therapeutic functions.
Medical body-worn transmitter. A MedRadio transmitter intended
to be placed on or in close proximity to the human body (e.g.,
within a few centimeters) used to facilitate communications with
other medical communications devices for purposes of delivering
medical therapy to a patient or collecting medical diagnostic
information from a patient.
* * * * *
Medical implant transmitter. A MedRadio transmitter in which
both the antenna and transmitter device are designed to operate
within a human body for the purpose of facilitating communications
from a medical implant device.
MedRadio programmer/control transmitter. A MedRadio transmitter
that operates or is designed to operate outside of a human body for
the purpose of communicating with a receiver, or for triggering a
transmitter,
[[Page 22709]]
connected to a medical implant device or to a medical body-worn
device used in the MedRadio Service; and which also typically
includes a frequency monitoring system that initiates a MedRadio
communications session.
MedRadio Service. Medical Device Radiocommunication Service.
MedRadio transmitter. A transmitter authorized to operate in the
MedRadio service.
* * * * *
0
20. Revise Subpart I to read as follows:
Subpart I--Medical Device Radiocommunication Service (MedRadio)
Sec.
95.1201 Eligibility.
95.1203 Authorized locations.
95.1205 Station identification.
95.1207 Station inspection.
95.1209 Permissible communications.
95.1211 Channel use policy.
95.1213 Antennas.
95.1215 Disclosure policies.
95.1217 Labeling requirements.
95.1219 Marketing limitations.
95.1221 RF exposure.
Subpart I--Medical Device Radiocommunication Service (MedRadio)
Sec. 95.1201 Eligibility.
Operation in the MedRadio service is permitted by rule and without
an individual license issued by the FCC. Duly authorized health care
professionals are permitted to operate MedRadio transmitters. Persons
may also operate MedRadio transmitters to the extent the transmitters
are incorporated into implanted or body-worn medical devices that are
used by the person at the direction of a duly authorized health care
professional; this includes medical devices that have been implanted in
that person or placed on the body of that person by or under the
direction of a duly authorized health care professional. Manufacturers
of medical devices that include MedRadio transmitters, and their
representatives, are authorized to operate transmitters in this service
for the purpose of demonstrating such equipment to duly authorized
health care professionals. No entity that is a foreign government or
which is acting in its capacity as a representative of a foreign
government is eligible to operate a MedRadio transmitter. The term
``duly authorized health care professional'' means a physician or other
individual authorized under state or federal law to provide health care
services. Operations that comply with the requirements of this part may
be conducted under manual or automatic control.
Sec. 95.1203 Authorized locations.
MedRadio operation is authorized anywhere CB station operation is
authorized under Sec. 95.405.
Sec. 95.1205 Station identification.
A station is not required to transmit a station identification
announcement.
Sec. 95.1207 Station inspection.
Any non-implanted MedRadio transmitter must be made available for
inspection upon request by an authorized FCC representative. Persons
operating implanted or body-worn MedRadio transmitters shall cooperate
reasonably with duly authorized FCC representatives in the resolution
of interference.
Sec. 95.1209 Permissible communications.
(a) Except for the purposes of testing and for demonstrations to
health care professionals, MedRadio programmer/control transmitters may
transmit only non-voice data containing operational, diagnostic and
therapeutic information associated with a medical implant device or
medical body-worn device that has been implanted or placed on the
person by or under the direction of a duly authorized health care
professional.
(b) Except as provided in Sec. 95.628(b) no MedRadio implant or
body-worn transmitter shall transmit except in response to a
transmission from a MedRadio programmer/control transmitter or in
response to a non-radio frequency actuation signal generated by a
device external to the body with respect to which the MedRadio implant
or body-worn transmitter is used.
(c) MedRadio programmer/control transmitters may be interconnected
with other telecommunications systems including the public switched
telephone network.
(d) For the purpose of facilitating MedRadio system operation
during a MedRadio communications session, as defined in Sec. 95.628,
MedRadio transmitters may transmit in accordance with the provisions of
Sec. 95.628(a) for no more than 5 seconds without the communications
of data; MedRadio transmitters may transmit in accordance with the
provisions of Sec. 95.628(b)(3) for no more than 3.6 seconds in total
within a one-hour time period without the communications of data;
MedRadio transmitters may transmit in accordance with the provisions of
Sec. 95.628(b)(2) for no more than 360 milliseconds in total within a
one-hour time period without the communications of data.
(e) MedRadio programmer/control transmitters may not be used to
relay information to a receiver that is not included with a medical
implant or medical body-worn device. Wireless retransmission of
information intended to be transmitted by a MedRadio programmer/control
transmitter or information received from a medical implant or medical
body-worn transmitter shall be performed using other radio services
that operate in spectrum outside of the MedRadio band.
Sec. 95.1211 Channel use policy.
(a) The channels authorized for MedRadio operation by this part of
the FCC Rules are available on a shared basis only and will not be
assigned for the exclusive use of any entity.
(b) To reduce interference and make the most effective use of the
authorized facilities, MedRadio transmitters must share the spectrum in
accordance with Sec. 95.628.
(c) MedRadio operation is subject to the condition that no harmful
interference is caused to stations operating in the 400.150-406.000 MHz
band in the Meteorological Aids, Meteorological Satellite, or Earth
Exploration Satellite Services. MedRadio stations must accept any
interference from stations operating in the 400.150-406.000 MHz band in
the Meteorological Aids, Meterological Satellite, or Earth Exploration
Satellite Services.
Sec. 95.1213 Antennas.
No antenna for a MedRadio transmitter shall be configured for
permanent outdoor use. In addition, any MedRadio antenna used outdoors
shall not be affixed to any structure for which the height to the tip
of the antenna will exceed three (3) meters (9.8 feet) above ground.
Sec. 95.1215 Disclosure policies.
Manufacturers of MedRadio transmitters must include with each
transmitting device the following statement:
``This transmitter is authorized by rule under the Medical Device
Radiocommunication Service (in part 95 of the FCC Rules) and must not
cause harmful interference to stations operating in the 400.150-406.000
MHz band in the Meteorological Aids (i.e., transmitters and receivers
used to communicate weather data), the Meteorological Satellite, or the
Earth Exploration Satellite Services and must accept interference that
may be caused by such stations, including interference that may cause
undesired operation. This transmitter shall be used only in accordance
with the FCC Rules governing the Medical Device Radiocommunication
Service. Analog
[[Page 22710]]
and digital voice communications are prohibited. Although this
transmitter has been approved by the Federal Communications Commission,
there is no guarantee that it will not receive interference or that any
particular transmission from this transmitter will be free from
interference.''
Sec. 95.1217 Labeling requirements.
(a) MedRadio programmer/control transmitters shall be labeled as
provided in part 2 of this chapter and shall bear the following
statement in a conspicuous location on the device:
``This device may not interfere with stations operating in the
400.150-406.000 MHz band in the Meteorological Aids, Meteorological
Satellite, and Earth Exploration Satellite Services and must accept any
interference received, including interference that may cause undesired
operation.''
The statement may be placed in the instruction manual for the
transmitter where it is not feasible to place the statement on the
device.
(b) Where a MedRadio programmer/control transmitter is constructed
in two or more sections connected by wire and marketed together, the
statement specified in this section is required to be affixed only to
the main control unit.
(c) MedRadio transmitters shall be identified with a serial number.
The FCC ID number associated with a medical implant transmitter and the
information required by Sec. 2.925 of this chapter may be placed in
the instruction manual for the transmitter and on the shipping
container for the transmitter, in lieu of being placed directly on the
transmitter.
Sec. 95.1219 Marketing limitations.
Transmitters intended for operation in the MedRadio Service may be
marketed and sold only for the permissible communications described in
Sec. 95.1209.
Sec. 95.1221 RF exposure.
MedRadio medical implant or medical body-worn transmitters (as
defined in appendix 1 to subpart E of part 95 of this chapter) are
subject to the radiofrequency radiation exposure requirements specified
in Sec. Sec. 1.1307 and 2.1093 of this chapter, as appropriate.
Applications for equipment authorization of implant devices operating
under this section must contain a finite difference time domain (FDTD)
computational modeling report showing compliance with these provisions
for fundamental emissions. The Commission retains the discretion to
request the submission of specific absorption rate measurement data.
[FR Doc. E9-11063 Filed 5-13-09; 8:45 am]
BILLING CODE 6712-01-C