[Federal Register: July 19, 2007 (Volume 72, Number 138)]
[Notices]
[Page 39630-39631]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19jy07-50]
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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Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance entitled ``Premarket Notification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 This draft guidance is intended to assist device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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Premarket Notification (510(k))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Submit written comments concerning this draft guidance to the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 dsmica@fda.hhs.gov 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]
BILLING CODE 4160-01-S