[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Draft Guidance on the Content and Format of Premarket 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availability of a draft guidance entitled ``Guidance on the Content and 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 The draft guidance provides specific directions 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 This draft guidance, dated April 26, 1995, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Small Manufacturers Assistance (HFZ-220), 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Submit written comments on the draft guidance to the Dockets Management 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 The draft guidance and received comments are available for 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