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Boston Scientific Corporation Waiver Extension Granted

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Released: August 23, 2011

Federal Communications Commission

DA 11-1427

Before the

Federal Communications Commission

Washington, D.C. 20554

In the Matter of
)
)

Boston Scientific
)
Corporation
)
ET Docket No. 05-331
)
Request 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
)

ORDER

Adopted: August 22, 2011

Released: August 23, 2011

By the Chief, Office of Engineering and Technology:

I.

INTRODUCTION

1. By this Order, we grant a request by Boston Scientific Corporation (Boston Scientific) to
extend the existing waiver of Section 15.205 of our rules for its Contak Renewal TR, Cognis, and Teligen
cardiac devices.1 Granting Boston Scientific’s request will permit these devices to continue to use the 90-
110 kHz band while Boston Scientific finalizes the development and introduction of replacement devices
that will not operate in that band. The present waivers are scheduled to expire on December 31, 2011,
and the extension granted herein will permit the continued manufacture and marketing of the subject
devices until June 30, 2013, or until one year after the Food and Drug Administration (FDA) approves
each device, whichever comes first.
2. This further extension is needed due to unanticipated delays in the completion of product
development for the respective devices or in the approval of the replacement devices by the FDA.
Because the health benefits provided by these devices will continue to be available to cardiac patients that
have come to rely on them, and because the risk of harmful interference to other authorized operations in
the band is extremely small, we conclude that good cause exists, and the public interest would be served
by, extending the existing waiver.2

II.

BACKGROUND

3. Boston Scientific manufactures several lines of implantable cardiac medical devices,
including cardiac resynchronization therapy devices (the Contak Renewal TR devices), cardiac
resynchronization devices with pacemakers (the Cognis devices), and cardioverter defibrillators (the
Teligen devices). As currently designed, these devices rely on inductive coupling to initiate
communication sessions that download data from, and modify the operational settings of, the implanted


1 See “Request for Further Extension of Waiver” in ET Docket No. 05-331, filed by Boston Scientific Corporation
on May 13, 2010.
2 See WAIT Radio v. FCC, 459 F.2d 1203, 1207 (D.C. Cir. 1972).

Federal Communications Commission

DA 11-1427

devices and to serve as a backup communications link.3 Because this inductive coupling technique
produces fundamental emissions in the 90-110 kHz restricted band, these devices do not comply with the
restricted band provisions of Section 15.205 our rules.4
4. On June 6, 2006, Boston Scientific first requested a waiver of Section 15.205 of the
Commission's rules for its Contak Renewal TR devices and the precursors of the Cognis and Teligen
devices described above, the PDM and PD2 families. The PDM and PD2 devices also used inductive
coupling at 90-110 kHz for their entire communications sessions, and at the time of the June 6, 2006
waiver request, Boston Scientific was well into the process of developing the Cognis and Teligen devices,
which rely on inductive coupling in the 90-110 kHz band only for the initiation phase of the
communications, thus significantly reducing its encroachment on the restricted 90-110 kHz band, and had
begun development of devices that would rely solely on transmissions in the 900 MHz band, as permitted
by our rules. Boston Scientific argued that a waiver of Section 15.205 would permit it sufficient time to
exit the 90-110 kHz band in an orderly manner while it developed the fully-compliant devices.
5. On November 16, 2006, the Chief of the Office of Engineering and Technology (OET), by
delegated authority, issued an Order granting a waiver of Section 15.205 of the Rules.5 Pursuant to the
Waiver Order, Boston Scientific was permitted to continue the manufacture and marketing of the Contak
Renewal TR devices for three years from the release date of the Waiver Order or until six months after
final regulatory approval of the Cognis and Teligen devices, whichever came first. With respect to the
Cognis and Teligen devices, the Waiver Order permitted their manufacture and marketing for three years
after the release date of the Order.6 This time frame was intended to minimize the time during which the
noncompliant devices would be used before the new, fully compliant products would enter the market.7
6. Subsequently, on July 11, 2007, in response to a petition for reconsideration filed by Boston
Scientific,8 the Chief of OET issued a further order (Waiver Modification Order) that modified the terms
of the original Waiver Order. This modification permitted Boston Scientific to continue the manufacture
and marketing of its next generation Cognis and Teligen series of devices for three years after FDA


3 See “Petition for Waiver” in ET Docket No. 05-331, filed by Boston Scientific Corporation on June 6, 2006, at
pages 5 and 12. The inductive coupling technique used by these devices initiates a data transfer by placing an
external "wand" reader over the patient's chest within centimeters of the implant. The wand and implant then
communicate on other (unrestricted) frequencies by sending and receiving data that provide information stored in
the device’s memory to allow physicians to monitor a patent’s cardiac events and the functioning of the implanted
system. In the event the primary communications channel does not function properly, the initial coupling link at 90-
110 kHz can also be used to transfer this data.
4 47 C.F.R. §15.205. 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 function, as a nature of their operation or use, with extremely low signal levels. These systems may be passive,
such as radio astronomy, or active, such as satellite downlinks.
5 See “In the Matter of Respironics, Inc. and Boston Scientific Corporation, 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,” 21 FCC Rcd 13450, Order, ET Docket No. 05-331, DA 06-2316 (2006) (Waiver
Order
). The Respironics waiver is not at issue herein.
6 Boston Scientific had requested that the waiver expire six years after FDA approval of the Cognis and Teligen
devices.
7 Waiver Order, supra, at para. 13.
8 See “Petition for Reconsideration” in ET Docket No. 05-331, filed by Boston Scientific on December 18, 2006.
2

Federal Communications Commission

DA 11-1427

approval, rather than three years from the date of the Order.9 The FDA granted approval for these devices
on May 8, 2008, which meant that the waiver for the Cognis and Teligen devices was set to expire on
May 8, 2011.
7. On July 14, 2009, the Chief of OET issued a further waiver (Contak TR Waiver Modification
Order) granting a March 6, 2009, Boston Scientific request to extend the expiration date of the waiver for
the Contak TR to the same date as the new waiver expiration date for the Cognis and Teligen devices.10
On September 15, 2010, the Chief of OET issued another waiver extension for the Contak TR, Cognis,
and Teligen devices, until December 31, 2011, in light of unplanned design enhancements and
unanticipated delays in bringing the next generation, compliant devices to market.11
8. Boston Scientific now requests a further extension of the waiver for all three of its current
product lines, i.e., the Contak Renewal TR, Cognis, and Teligen devices, until the earlier of twelve
months after FDA approval for each device, or June 30, 2013, whichever is sooner. In support of this
request, Boston Scientific states that, despite investing millions of dollars in the redesign of its products to
comply with FCC regulations, it has experienced unanticipated delays as a result of unplanned but
necessary further design enhancements. It submits that it is now in the final stages of development for the
next generation, compliant products but that the time remaining in its current waiver is not adequate to
complete reliability testing, FDA review and approval, and introduction of the new products into the
medical community. It expects FDA approval could take until the middle of 2012, and needs time for an
orderly introduction of and transition to the new systems.

III.

DISCUSSION

9. We find that the particular circumstances that supported the grant of the previous Waiver
Order, the subsequent Waiver Modification Order, and the related Contak TR Waiver Modification Order
also support our grant herein of a relatively short extension of the waivers for the Contak Renewal TR,
Cognis, and Teligen devices as requested by Boston Scientific.
10. As we stated in the previous Orders involving these products, these waivers present an
unusual and compelling public interest situation in which patients and their caregivers rely on the devices
at issue for health- and life-critical purposes.12 We acknowledge Boston Scientific’s continued efforts to
transition its production to fully compliant devices and conclude that, in furtherance of achieving this
desirable goal, it is reasonable and appropriate for us to accommodate the additional development delays


9 See “In the Matter of Respironics, Inc. and Boston Scientific Corporation, 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,” 22 FCC Rcd 12881, Order, ET Docket No. 05-331, DA 07-3160 (2007) (Waiver
Modification Order
).
10 “Request for Extension of Waiver” (March 6, 2009). Boston Scientific asked for and was granted an extension
until the earlier of (i) May 8, 2011, or (ii) 90 days after the FDA approval date for fully rules-compliant
replacements for the Contak Renewal TR. In the Matter of Respironics, Inc. and Boston Scientific Corporation,
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, Order in ET Docket No. 05-331, 24 FCC
Rcd 9089 (Office of Engineering and Technology, 2009). The FDA did not grant approval by May 8, 2008, and
consequently May 8, 2011 became the default date for expiration of the waivers.
11 In the Matter of Respironics, Inc. and Boston Scientific Corporation, 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, Order in ET Docket No. 05-331, 25 FCC Rcd 13143 (Office of Engineering and
Technology, 2010) (Waiver Extension Order).
12 See Waiver Modification Order, supra, at para. 10.; Contak TR Waiver Modification Order, supra, at paras. 11,
12; Waiver Extension Order, supra, at para. 10.
3

Federal Communications Commission

DA 11-1427

that have occurred. The extension granted herein will ensure that the treatment benefits provided by these
devices will continue to be available to patients until FCC-compliant replacements can be brought to
market in an orderly manner, and the critical benefits provided by these devices continue to present a
significant public interest basis for the requested relief. As we have previously determined, these cardiac
devices present an extremely small risk of harmful interference to other authorized operations.13 Given
the remote likelihood of such interference, we find that grant of this waiver will not contravene the
underlying purpose of Section 15.205 of the Rules. Because these devices are already operating pursuant
to the Waiver Extension Order, there are no significant costs associated with extending the waiver. This
decision remains consistent with our earlier determination to minimize the time for which noncompliant
devices would be used before new, fully compliant products would enter the market.14
11. Accordingly, consistent with our earlier actions with respect to this matter, we find good
cause to extend the waiver of Section 15.205 of our rules for the Contak Renewal TR, Cognis, and
Teligen devices as requested.

IV.

ORDERING CLAUSES

12. Accordingly, pursuant to Sections 4(i), 302, 303(e), 303(r) and 405 of the Communications
Act of 1934, as amended (47 U.S.C. §§ 154(i), 302, 303(e), 303(r) and 405), and Section 1.106(a)(1) of
the Commission’s rules (47 C.F.R. § 1.106(a)(1)), IT IS ORDERED that Boston Scientific may continue
to manufacture and market the “Contak Renewal TR,” “Cognis,” and “Teligen” product lines of cardiac
medical devices until the earlier of twelve months after FDA approval for each device or June 30, 2013,
whichever comes first for each device.
13. It is FURTHER ORDERED that Boston Scientific MUST SHOW that it has obtained FDA
approval, including the date of such approval, as part of its submission for equipment certification of the
FCC rules-compliant replacement for the subject devices.
FEDERAL COMMUNICATIONS COMMISSION
Julius P. Knapp, Chief
Office of Engineering and Technology


13 As stipulated in the original Waiver Order, supra, the Contak TR Waiver Modification Order, supra, and the
Waiver Extension Order, supra, the temporary waiver embodied by this Order only applies to the constraints on
emissions in the restricted frequency bands as specified in Section 15.205 of the Commission’s rules. This waiver
does not provide relief of the requirements of Section 15.5(b) that the subject devices do not cause interference to
and must accept interference from other authorized stations, radiators or equipment. See Waiver Extension Order,
supra
at n. 13. (We do note that LORAN-C operations (in the 90-110 kHz band) have been discontinued. See,
http://www.navcen.uscg.gov/?pageName=loranMain.)
14 See, para. 5, supra, n.7, supra.
4

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