[Federal Register Volume 78, Number 157 (Wednesday, August 14, 2013)]
[Notices]
[Pages 49529-49530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19686]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2006-D-0300] (formerly Docket No. 2006D-0504)
Radio Frequency Wireless Technology in Medical Devices; Guidance
for Industry and Food and Drug Administration Staff; 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 guidance entitled ``Radio Frequency Wireless
Technology in Medical Devices; Guidance for Industry and Food and Drug
Administration Staff.'' This guidance document is intended to assist
industry and FDA staff in identifying and appropriately addressing
specific considerations related to the incorporation and integration of
radio frequency (RF) wireless technology in medical devices. This
guidance discusses issues that may affect the safe and effective use of
medical devices that incorporate RF wireless technology, including
selection of wireless technology, quality of service, coexistence,
security, and electromagnetic compatibility, and provides
recommendations for information to be included in FDA premarket
submissions for such devices.
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Radio Frequency Wireless Technology in Medical
Devices; Guidance for Industry and Food and Drug Administration Staff''
to the Division of Small Manufacturers, International and Consumer
Assistance, Center for Devices and Radiological Health (CDRH), Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613,
Silver Spring, MD 20993-0002 or Office of Communication, Outreach, and
Development (HFM-40), Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist those offices in processing your request, or fax your request to
CDRH at 301-847-8149. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Donald Witters, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1130, Silver Spring, MD 20993-0002, 301-796-2483;
or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA developed this guidance document to assist industry, systems
and service providers, consultants, FDA staff, and others involved in
the design, development, and evaluation of RF wireless technology in
medical devices. The use and deployment of RF wireless technology in
and around medical devices is an increasing concern because the
electromagnetic environments where medical devices are used might
contain many sources of RF energy, and the RF wireless emissions from
one product or device could potentially affect the function of another.
The guidance recommends that manufacturers address the potential issues
that relate to the incorporation of RF wireless technology that may
affect the safe and effective use of medical devices.
The draft guidance document and comment period were announced in
the Federal Register on January 3, 2007 (72 FR 137). The comment period
closed on April 2, 2007. Over 25 companies, numerous organizations, and
many individuals provided around 180 comments. FDA considered all of
the comments and revised the guidance where appropriate.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on radio frequency wireless technology in
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 guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov or the CBER
Internet site at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. To
receive ``Radio Frequency Wireless Technology in Medical Devices;
Guidance for Industry and Food and Drug Administration Staff,'' you may
either send an email request to [email protected] to receive an
electronic copy of the document or send a fax request to 301-847-8149
to receive a hard copy. Please use the document number 1618 to
[[Page 49530]]
identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This 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, subpart E 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; the collections of
information in 21 CFR part 814, subpart H have been approved under OMB
control number 0910-0332; and the collections of information in 21 CFR
part 820 have been approved under OMB control number 0910-0073.
V. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (See ADDRESSES). It is only necessary to
send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.
Dated: August 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19686 Filed 8-13-13; 8:45 am]
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