[Federal Register: January 3, 2007 (Volume 72, Number 1)]
[Notices]
[Page 137-138]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03ja07-55]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0504]
Draft Guidance for Industry and Food and Drug Administration
Staff; Radio-Frequency Wireless Technology in Medical Devices;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Draft Guidance for
Industry and FDA Staff; Radio-Frequency Wireless Technology in Medical
Devices.'' This draft guidance document addresses issues relevant to
the safe and effective use of radio frequency (RF) wireless technology
in medical devices, including wireless coexistence, performance, data
integrity, security, and electromagnetic compatibility (EMC). These
issues involve all stages of the product life cycle and should be
considered in preparing premarket submissions; identifying,
documenting, and implementing product design requirements, as well as
design verification and validation; and risk management processes and
procedures.
DATES: Submit written or electronic comments on the draft guidance by
April 2, 2007.
ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Draft Guidance for Industry and FDA Staff: Radio-
Frequency Wireless Technology in Medical Devices'' to the Division of
Small Manufacturers, International, and Consumer Assistance (HFZ-220),
Center for Devices and Radiological Health, Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 240-276-3151.
Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
FOR FURTHER INFORMATION CONTACT: Donald Witters, Center for Devices and
Radiological Health (HFZ-130), Food and Drug Administration, 12725
Twinbrook Pkwy., Rockville, MD 20852, 301-827-4955.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has developed this draft guidance document to assist industry,
systems and service providers, consultants, FDA staff, and others in
the design, development, and evaluation of RF wireless technology in
medical devices. The RF wireless emissions from one product or device
can affect the function of another, the electromagnetic environments
where medical devices are used may contain many sources of RF energy,
and the use of RF wireless technology in and around medical devices is
increasing. As a result, the draft guidance recommends that
manufacturers address concerns about the potential effects of the use
of RF wireless technology in and around medical devices on the ability
of medical devices to function properly and the resultant safety of
patients and operators.
This draft guidance references national and international standards
and discusses some of FDA's regulatory requirements, including
premarket requirements (21 CFR parts 807 and 814). The draft guidance
document also discusses quality system requirements as they
specifically apply to RF wireless technology in medical devices,
including design and development activities (21 CFR part 820).
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on RF wireless
technology in and around medical devices. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive ``Draft Guidance for Industry and
FDA Staff; Radio-Frequency Wireless Technology in Medical Devices'' you
may either send an e-mail request to dsmica@fda.hhs.gov to receive an
electronic copy of the document or send a fax request to 240-276-3151
to receive a hard copy. Please use the document number 1618 to identify
the guidance you are requesting.
CDRH maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh.
A search capability for all CDRH guidance documents is available
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets
.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 801 have been approved under
OMB control number 0910-0485; the collections of information in 21 CFR
part 807 have been approved under OMB control number 0910-0120; the
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231; and the collections
[[Page 138]]
of information in 21 CFR part 820 have been approved under OMB control
number 0910-0073.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. Submit a single copy of electronic comments or submit two
paper copies of any mailed comments, except that individuals may submit
one paper copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
Dated: December 19, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-22449 Filed 12-29-06; 8:45 am]
BILLING CODE 4160-01-S