[Federal Register Volume 61, Number 236 (Friday, December 6, 1996)]
[Notices]
[Pages 64755-64756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31053]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95D-0413]
Draft Guidance on the Content and Format of Premarket
Notification (510(k)) Submissions for Liquid Chemical Germicides;
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availability of a draft guidance entitled ``Guidance on the Content and
Format of Premarket Notification (510(k)) Submissions for Liquid
Chemical Germicides.'' The draft guidance provides specific directions
to manufacturers regarding information and data that should be
submitted to FDA in a premarket notification (510(k)) submission for a
liquid chemical germicide. This draft guidance, dated April 26, 1995,
replaces a previous version dated January 31, 1992.
DATES: Written comments by March 6, 1997.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Small Manufacturers Assistance (HFZ-220),
Center for Devices and Radiological Health, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-6597
(toll free outside of MD 1-800-638-2041). Send two self-addressed
adhesive labels to assist that office in processing your requests.
Submit written comments on the draft guidance to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm.
1-23, Rockville, MD 20857. Requests and comments should be identified
with the docket number found in brackets in the heading of this
document. The draft guidance and received comments are available for
public examination in the Dockets Management Branch between 9 a.m. and
4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Chiu S. Lin, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 2085O, 301-443-8913.
SUPPLEMENTARY INFORMATION: FDA regulates the introduction of medical
devices into interstate commerce. A person intending to market a liquid
chemical germicide medical device must submit a premarket notification
under section 510(k) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360(k)) to FDA before introducing the device into interstate
commerce. Regulations governing the general content and format of
510(k) submissions (21 CFR part 807) and other regulatory requirements
are discussed in guidance documents available from the Center for
Devices and Radiological Health, Division of Small Manufacturers
Assistance (address above). The intent of this draft guidance is to
provide 510(k) applicants with specific directions regarding
information and data that should be submitted to FDA in a 510(k)
submission for a liquid chemical germicide medical device.
The effective use of chemical germicides is important in preventing
nosocomial infections. Comprehensive, scientifically sound criteria for
the evaluation of chemical germicides is essential to help ensure that
these agents are safe and effective for their intended use when used
according to their labeling. FDA recognizes the importance of providing
applicants, and other interested parties, with the agency's 510(k)
submission criteria for chemical germicides in order to facilitate
assembly of necessary data, to maintain consistency of review, and to
provide for a more efficient regulatory process. The draft guidance is
predicated upon the legal principles of the 510(k) process. It also
draws upon the longstanding regulatory and scientific basis for
evaluation of germicides by the Federal government. It is a product of
interactions with interested parties in industry, government, and
academia as well as with infection control and other health care
professionals.
This is a draft guidance document, and as such does not create or
confer any rights for or on any person and does not operate to bind FDA
or others; however, it does represent FDA's recommendations at this
time. The draft guidance is not static and, thus, will be periodically
revised to remain current with the state of the art in this fast
changing area.
Interested persons may on or before March 6, 1997, submit to the
Dockets Management Branch (address above) written comments regarding
this draft guidance. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. The draft guidance and received comments may
[[Page 64756]]
be seen in the office above between 9 a.m. and 4 p.m., Monday through
Friday.
Dated: November 20, 1996.
D. B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 96-31053 Filed 12-05-96; 8:45 am]
BILLING CODE 4160-01-F
