[Federal Register Volume 62, Number 169 (Tuesday, September 2, 1997)]
[Notices]
[Pages 46366-46367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23181]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0333]


Reexamination of the Evaluation Process for Liquid Chemical 
Sterilants and High Level Disinfectants; 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 position paper entitled ``Reexamination of the 
Evaluation Process for Liquid Chemical Sterilants and High Level 
Disinfectants.'' The position paper is soliciting input from industry, 
users' groups, other regulatory agencies, and academia on FDA's 
approaches to improving the evaluation of liquid chemical sterilants 
and high level disinfectants.
DATES: Written comments by December 1, 1997.
ADDRESSES: Submit written requests for single copies of the position 
paper 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 position paper 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. A copy of the position paper and received comments are 
available for public examination in the Docket 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-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-0616.

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 (the 
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 (part 807 (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 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 evaluation criteria for 
chemical germicides in order to facilitate the assembly of necessary 
data, to maintain consistency of review, and to provide for a more 
efficient regulatory process. The purpose of this position paper is to 
solicit input from industry, users' groups, other regulatory agencies, 
and academia on FDA's approaches to improving the evaluation of liquid 
chemical germicides. The comments that FDA receives in response to this 
position paper will help it in assessing the current guidance and in 
developing the approach that will be used in future guidances for these 
products.

[[Page 46367]]

    This position paper represents the agency's current thinking on the 
Reexamination of the Evaluation Process for Liquid Chemical Sterilants 
and High Level Disinfectants. It does not create or confer any rights 
for or on any persons 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, regulations, or both.
    Interested persons should submit to the Dockets Management Branch 
(address above) written comments on the ``Reexamination of the 
Evaluation Process for Liquid Chemical Sterilants and High Level 
Disinfectants'' by December 1, 1997. 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. Received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
    Persons interested in obtaining a copy of the position paper may do 
so by using the World Wide Web (WWW). The Center for Devices and 
Radiological Health (CDRH) maintains an entry on the WWW for easy 
access to information including text, graphics, and files that may be 
downloaded to a PC with access to the Web. Copies of the position paper 
can be accessed from the CDRH home page at ``http://www.fda.gov/cdrh.''

    Dated: August 18, 1997.
D. B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 97-23181 Filed 8-29-97; 8:45 am]
BILLING CODE 4160-01-F