**Before the**

**Federal Communications Commission**

**Washington, D.C. 20554**

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| In the Matter of                 | *  | ET Docket No. 05-331         |
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| Respironics, Inc. and Boston     | ** |                              |
| Scientific Corporation           |    |                              |
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| Requests for Waiver of Section   | *) |                              |
| 15.205 of the Commission's Rules | ** |                              |
| to Permit the marketing and      |    |                              |
| operation of certain medical     | *  |                              |
| communications devices that      | *) |                              |
| operate in the 90-110 kHz band   | ** |                              |
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**ORDER**

**Adopted: November 16, 2006 Released: November 16, 2006**

By the Chief, Office of Engineering and Technology:

# INTRODUCTION

1\. By this action, we grant the Requests for Waiver filed by
Respironics, Inc. (Respironics) on October 28, 2005 and by Boston
Scientific Corporation (Boston Scientific) on June 6, 2006, to permit
the marketing and operation of certain medical communications devices
that are not in compliance with the "restricted band" provisions in
Section 15.205 of the Commission's rules.[^1] Specifically, we permit
Respironics to market, for a limited period of time and in limited
number, its ActiReader devices, and we permit Boston Scientific to
manufacture and market, for a limited period of time, its implantable
cardiac rhythm management devices. We find that there is good cause to
grant these waivers, and that the public interest will be served by
doing so. In this regard, we conclude that grant of these waivers will
afford medical patients the important health benefits provided by the
Respironics and Boston Scientific devices for which there currently are
no reasonable alternatives and would not contravene the underlying
purposes of our rules for unlicensed devices.

# BACKGROUND

2\. Under Section 15.205 of the Commission's rules for unlicensed radio
devices, intentional radiators generally are not permitted to operate in
certain sensitive or safety-related frequency bands that are designated
as "restricted bands." The restricted bands listed in Section 15.205 are
bands employed by radio services that must function, as a nature of
their operation, using extremely low received signal levels. These
systems may be passive, such as radio astronomy, or active, such as
satellite down links and wildlife tracking systems.

3\. Respironics develops, manufactures and distributes products and
programs around the world that manage sleep disordered breathing,
chronic obstructive pulmonary disease, asthma, allergies and sinusitis,
infant jaundice, apnea, heart failure, and restrictive lung
disorders.[^2] Respironics recently acquired another company that
develops and sells sleep and physiological monitoring products,
including a series of activity monitors that are used to monitor sleep
patterns, physical activity/calorie expenditures, and other indicia of
human activity and behavior. These last products are the subject of this
waiver consideration. In this family of products, an "ActiWatch" is worn
by a patient/subject and is equipped with a highly sensitive
accelerometer and a data recorder. The collected data is periodically
transferred from the ActiWatch to an "ActiReader" via a low-power,
short-range wireless link established by emissions from the ActiReader.
This link is active only during periods of such data transfer. The data
is then downloaded from the ActiReader to a storage device, typically a
computer. The resulting activity record can be used to study sleep/wake
patterns, sleep disorders, circadian rhythm disorders, basic activity
levels, and similar conditions. With this information, practitioners can
diagnose ailments and design treatments accordingly.

4\. The ActiWatch and ActiReader devices are designed to communicate
using the fundamental frequency of 104 kHz, which is within the 90-110
kHz "restricted band" that is prohibited from use by unlicensed devices
under Section 15.205(a) of our rules. This band is reserved for use by
the Federal Government, and is currently used by LORAN-C, a
radionavigation system provided by the Federal Government for civil
marine use and en route supplemental navigation aid for civil aviation.
Respironics contends that its ActiReader devices pose a negligible risk
of causing interference, as their RF emissions are 50 dB below the level
permitted for spurious emissions by intentional radiators in the subject
restricted band. It submits that emissions from ActiReader units should
not be detectable beyond a few millimeters from the device.[^3]
Moreover, according to Respironics, such emissions generally occur only
a few times a day for each ActiReader unit,[^4] occur in controlled
settings in a limited number of predictable locations under the
supervision of a trained operator, and last for only a few seconds on
each occasion. Respironics seeks a waiver of Section 15.205(a)[^5] to
permit the use of existing ActiReaders and the production and sale of an
additional 1,000 ActiReaders over the next 18 months, during which time
it will redesign this product to be compliant with our rules.[^6]

5\. Boston Scientific is a worldwide manufacturer of medical devices for
cardiac patients. These devices include implantable pacemakers (the
"PDM" family), cardioverter defibrillators (the "PD2" family), and
cardiac resynchronization therapy (the "Contak Renewal TR" family)
devices. These devices deliver electrical stimuli to the heart when
needed to treat abnormal heart rhythms. They also store information on a
patient's cardiac functioning, as well as the functioning of the device
itself. Boston Scientific indicates that the data collected and stored
in these devices is downloaded by inductive

coupling with a "wand" that is placed over the patient's chest within
inches of the implant to receive extremely low level transmissions. The
devices' operational settings can also be adjusted through the same
process. The Boston Scientific "wand" reader devices produce fundamental
emissions in the 90-110 kHz restricted band, and thus violate the
restricted band provisions of our rules.[^7] Boston Scientific states
that it is now developing "next generation" devices (the "Teligen,"
"Cognis," and "Ingenio" families) that would also use inductive coupling
on frequencies in the 90-110 kHz band, but only to initiate a
communications session and as a backup means of data communications. It
indicates that these new devices would transmit in the 900 MHz band as
their primary means of data transfer. Boston Scientific also submits
that it intends to develop new product lines that will eliminate
inductive coupling in the 90-110 kHz band altogether.

6\. Boston Scientific argues that interference from its current and next
generation devices is "virtually impossible." It submits that its
current devices operate with a field strength that is 70 dB below the
level permitted for spurious emissions, and that its next generation
devices will operate with a field strength 50 dB below the spurious
emissions limit. Boston Scientific states at these levels its wands for
reading the data from implantable medical devices are unlikely to cause
interference to any incumbent licensed user.[^8] It further submits that
these devices operate for only a few moments at a time, and only in a
hospital or medical clinic setting, away from other likely sources or
recipients of interference. Boston Scientific indicates that its next
generation devices will operate in the 90-110 kHz restricted band for a
cumulative total of about two seconds per year per unit. It notes that
the potential for interference is further limited by the fact that the
frequencies affected by the subject devices are used by the federal
government only for LORAN-C devices, which are located in airplanes and
boats, not in the vicinity of a hospital or clinic, where the inductive
communications sessions would typically occur.

7\. Boston Scientific also contends that it supplies 30% of all cardiac
devices in the U.S., and that taking its product off the market would
result in a shortage of such products available for patients that need
them, and also reduce market competition in the field. It therefore
seeks a waiver[^9] of Section 15.205(a) to permit the continued
manufacture and marketing of its current devices and its next generation
devices, as well, until the development of non-inductive coupling
devices can be completed and the devices can be introduced into the
market for use.[^10] It requests a two-year waiver for the PDM and PD2
devices and a three-year waiver for the Contak Renewal TR devices while
it brings its next generation devices to market. For the next generation
devices, Boston Scientific requests a waiver for a period of six years
after each device's respective market release following FDA approval.
Such a waiver, it submits, will permit Boston Scientific to "exit the
band" in an orderly manner consistent with the compelling public
interest in the availability of these devices. It asserts that the
lengths of time it requests will ensure the new devices' thorough and
safe development, including the multiyear period of testing and FDA
approval, and the adequate availability of replacement devices for
cardiac patients across the country. With respect to permitting the next
generation products that are not yet in the market, Boston Scientific
also argues that these products would at least greatly reduce, if not
eliminate, the interference potential in the restricted band as compared
to the current products.[^11]

# III. DISCUSSION {#iii.-discussion .Style-Heading-1-+-Times-New-Roman-Not-All-caps .unnumbered}

8\. We find that temporary waivers are warranted for the Respironics and
Boston Scientific devices considered herein to operate as currently
designed for a limited period of time while compliant devices are
developed and produced. This is an unusual and compelling situation, in
which health- and life-critical technology is already being relied on by
patients and their caregivers, and there is little likelihood of
interference, given the operational parameters and location of use of
each of the devices when transmitting. Accordingly, there is good cause
for granting these waivers and it is in the public interest to do
so.[^12] To deny these waivers would not serve the underlying purpose of
the rules, as it is unlikely that grant of the waivers would lead to the
harm that the rule is intended to avoid, *i.e.*, interference to primary
users of the band. And, finally, Respironics, Boston Scientific, and the
patients their devices will serve have no reasonable alternative at this
time to obtain the important benefits afforded by the devices.[^13] The
waiver for the Respironcs ActiReader is granted for 12 months from the
release of this Order. The waivers for the Boston Scientific devices are
for various periods as specified below, with a maximum of three years
from the release date of this Order.

9\. These temporary waivers only apply to the constraints on emissions
in the restricted frequency bands as specified in Section 15.205 of the
Commission's rules.[^14] These waivers do not provide relief of the
requirements of Section 15.5(b). Specifically, the requirement that
interference to the subject Respironics Inc., and Boston Scientific
Corporation products that may be caused by the operation of a LORAN-C
radio station must be accepted.

10\. *Respironics*. The Respironics ActiReader/ActiWatch system is a
valuable tool for research into and treatment of significant medical
ailments, as described above, and to our knowledge, there are no
alternatives available now or in the near future. Given the extremely
low power, infrequency of use, locations of use, and limited number of
these devices currently available and as limited in the future by our
waiver (12 months and 1000 units), these devices pose a negligible risk
of causing the interference our rules are designed to protect. While it
is apparently possible to design products which perform the
ActiReader/ActiWatch functions that are compliant with the rules,
without this waiver, Respironics would be unable to provide a continuous
supply of this valuable and unique product to doctors and researchers
while it is redesigning its product and manufacturing a new supply.
Respironic's request for 18 months was made in October, 2005, and we can
reasonably project that it has made progress in its new design since
that time. Accordingly, we will permit Respironics to continue to
manufacture and sell a maximum of 1000 ActiReaders as currently designed
as described in this Order for a period of 12 months after the release
date of this Order.

11\. *Boston Scientific*. Boston Scientific's subject cardiac devices
provide life-saving technology to cardiac patients. Their monitoring
function, which is enabled by the inductive coupling at issue, provides
an important element of patient care. Moreover, the devices themselves
can be adjusted as needed through the communication session. Given their
technical and operational parameters, these devices, too, pose a
negligible likelihood of interference. While it is apparently possible
to design and manufacture functionally equivalent devices which comply
with the rules, as Boston Scientific indicates that it is in the process
of doing, the short-term product shortage that would result from taking
the current devices off the market without a phase-out period would
likely be detrimental to the public, and specifically medical patients
and their families who benefit from their use. Additionally, while
Boston Scientific's planned next generation products also fail to comply
fully with the rules they will pose significantly less interference
potential than the current devices, despite a higher field
strength,[^15] because they will be operated at a much lower duty cycle
of only about two cumulative seconds per year. Accordingly, we believe
that permitting these next generation products to replace the current
products as part of the phase-out until fully-compliant products can be
introduced will reduce the interference potential of the Boston
Scientific cardiac medical products at issue here. We note, too, that
the next generation devices include improved technology and design to
improve performance and enhance patient safety.

12\. Boston Scientific has not provided sufficient justification for the
extensive non-compliance period it requests, which easily could stretch
to eight to ten years. General references are made to the time required
for careful design and for obtaining FDA regulatory approval, affecting
the time window during which the next generation devices could be sold,
as well as to the millions of dollars claimed to have been spent on
development of those devices. We do not disregard these assertions.
However, we note that such business concerns, while understandably of
import to an individual manufacturer such as Boston Scientific, do not
address the more pertinent issue of whether this particular rule waiver
would serve the greater public interest. We do not find it apparent that
the extensive period of time requested by Boston Scientific should be
necessary to design and receive approval for devices that are fully
compliant with our rules. Moreover, it is not apparent that the market
could not adjust to accommodate Boston Scientific's patients, if
necessary, over a shorter period of time than the eight to ten years
requested.

13\. Accordingly, we will permit Boston Scientific a maximum of three
years to continue to manufacture and sell any of the noncompliant
devices described in its waiver petition.[^16] More specifically, we
will permit Boston Scientific to continue to manufacture and sell its
current PDM and PD2 devices for a period of two years or until six
months after final regulatory approval of their respective new
replacement devices, which ever comes first in each case. We will also
permit Boston Scientific to continue to manufacture and sell its current
Contak Renewal TR devices for a period of three years or until six
months after final regulatory approval of its new replacement device,
which ever comes first. Finally, we will permit Boston Scientific to
manufacture and sell its next generation devices (after they receive
regulatory approval) until three years from the date of this Order. We
believe that these time periods strike an appropriate balance between
providing some degree of relief to the parties under the special
circumstances presented while reasonably minimizing the amount of time
during which non-compliant devices operate in the band, and thus best
serve the public interest in this case.

# v. ORDERING CLAUSE {#v.-ordering-clause .unnumbered}

14\. Accordingly, pursuant to Sections 4(i), 302, 303(e), and 303(r) of
the Communications Act of 1934, as amended (47 U.S.C. §§ 154(i), 302,
303(e), and 303(r)) and Section 1.3 of the Commission's rules (47 C.F.R.
§ 1.3), and under the authority delegated in sections 0.31 and 0.241 of
the Commission\'s rules (47 C.F.R. §§ 0.31, 0.241), IT IS ORDERED that
the following waivers are granted:

1\) Respironics, Inc. is permitted to manufacture and sell for a period
of 12 months from the release of this Order a maximum number of 1000
uncertified ActiReader units as described in this Order and in its
petition for waiver.

2\) Boston Scientific Corporation is permitted to manufacture and sell
its uncertified devices as described in this Order and in its petition
for waiver as follows:

a\) PDM and PD2 devices for two years after release of this Order, or
until six months after final regulatory approval of their next
generation replacement devices, whichever comes first

b\) Contak Renewal TR devices for three years after release of this
Order or until six months after final regulatory approval of their next
generation replacement devices, whichever comes first;

c\) Cognis, Teligen, and Ingenio devices for three years after the
release date of this Order.

FEDERAL COMMUNICATIONS COMMISSION

Julius P. Knapp, Chief

Office of Engineering and Technology

[^1]: 47 C.F.R. § 15.205.

[^2]: Respironics Petition at 2.

[^3]: Respironics Petition for Waiver, Exhibit 1. Respironics further
    notes that ActiReader emission levels are below the noise floor for
    many measuring instruments.

[^4]: According to Respironics, there are approximately 12,000
    ActiWatches and 1500 ActiReaders in the field. This is an average of
    eight Actiwatches for each ActiReader, which suggests that each
    ActiReader functions, on average, approximately four times per day
    for a total of less than ten seconds per day per ActiReader.

[^5]: Respironics' petition was placed on public notice on December 5,
    2005 (Public Notice DA 05-3142). Comments and reply comments thereon
    were filed by Respironics and James Edwin Whedbee, all of which
    support the waiver request.

[^6]: We note that, according to Respironics, approximately 1,500
    noncompliant and uncertified ActiReaders are already the field in
    clinics, hospitals, and research labs, and that, as a separate
    matter, the Commission is considering appropriate enforcement action
    with respect to these devices.

[^7]: See n. 1, *supra*.

[^8]: Boston Scientific Petition for Waiver, Attachment B.

[^9]: Boston Scientific's petition was not placed on public notice,
    given the recent Respironics petition which raised essentially the
    same issue, and the paucity of response to that public notice.

[^10]: Boston Scientific asserts that approximately 85,000 people use
    these implants today, and estimates that another 12,500 people would
    receive them over the next three years under a waiver. As a separate
    matter, the Commission is considering appropriate enforcement action
    with respect to those devices manufactured and sold without
    appropriate equipment certification.

[^11]: We note that Boston Scientific has filed a Petition for Rule
    Making, which is now the subject of an ongoing Commission
    proceeding. *See, Notice of Inquiry, Notice of Proposed Rulemaking,
    and Order* in ET Docket No. 06-135, FCC 06-103, released July 18,
    2006, 71 FR 43682, August 2, 2006.

[^12]: *See* *WAIT Radio v. FCC*, 459 F.2d 1203, 1207 (D.C. Cir. 1972).

[^13]: *See* 47 C.F.R. § 1.925.

[^14]: *See* 47 C.F.R. § 15.205.

[^15]: *See* para. 6, *supra*.

[^16]: Devices that are implanted in patients under the provisions of
    these rules will be permitted to continue to operate indefinitely.