[Federal Register Volume 72, Number 138 (Thursday, July 19, 2007)]
[Notices]
[Pages 39630-39631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-13952]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0201]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Premarket Notification Submissions for Medical Devices That 
Include Antimicrobial Agents; 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availability of the draft guidance entitled ``Premarket Notification 
(510(k)) Submissions for Medical Devices That Include Antimicrobial 
Agents.'' This draft guidance is intended to assist device 
manufacturers interested in preparing premarket notification (510(k)) 
submissions for their medical devices that include antimicrobial 
agents. This guidance recommends testing and labeling for 510(k) 
submissions for devices that include antimicrobial agents. It is 
intended as a supplement to other device-specific guidance issued by 
the Center for Devices and Radiological Health (CDRH).

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by October 17, 2007.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Premarket Notification (510(k)) 
Submissions for Medical Devices That Include Antimicrobial Agents'' 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. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit written comments concerning this draft guidance to the 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. Identify comments 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Michelle Rios, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3747.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years there has been increased interest in adding 
antimicrobial agents to medical devices for specific or limited 
indications for use, such as reduction or prevention of a device-
related infection, or reduction or inhibition of colonization of a 
medical device. FDA developed this draft guidance to assist device 
manufacturers in preparing premarket notification (510(k)) submissions 
for medical devices that include antimicrobial agents.

[[Page 39631]]

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 ``Premarket 
Notification (510(k)) Submissions for Medical Devices That Include 
Antimicrobial Agents.'' 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 ``Premarket Notification (510(k)) 
Submissions for Medical Devices That Include Antimicrobial Agents,'' 
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 1557 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 807 have been approved under 
OMB control number 0910-0120; the collections of information in 21 CFR 
part 801 have been approved under OMB control number 0910-0485.

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 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: July 12, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13952 Filed 7-18-07; 8:45 am]
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