[Federal Register Volume 72, Number 1 (Wednesday, January 3, 2007)]
[Notices]
[Pages 137-138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-22449]


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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Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance entitled ``Draft Guidance for 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 This draft guidance document addresses issues relevant to 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Draft Guidance for Industry and FDA Staff: Radio-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    Submit written comments on the draft guidance to the Division of 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 [email protected] 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