E6-22449. Draft Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency Wireless Technology in Medical Devices; Availability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.

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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Draft Guidance for Industry and FDA Staff; Radio-Frequency Wireless Technology in Medical Devices.” This draft guidance document addresses issues relevant to the safe and effective use of radio frequency (RF) wireless technology in medical devices, including wireless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Submit written or electronic comments on the draft guidance by April 2, 2007.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Submit written requests for single copies of the draft guidance entitled “Draft Guidance for Industry and FDA Staff: Radio-Frequency Wireless Technology in Medical Devices” to the Division of Small Manufacturers, International, and Consumer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Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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FDA has developed this draft guidance document to assist industry, systems and service providers, consultants, FDA staff, and others in the design, development, and evaluation of RF wireless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 [e-mail] 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 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.