[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]
BILLING CODE 4160-01-P