[Federal Register Volume 68, Number 17 (Monday, January 27, 2003)]
[Notices]
[Pages 3887-3888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1684]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0525]


Medical Devices; Chemical Indicators Premarket Notification 
[510(k)] Submissions; Draft Guidance for Industry and FDA; Availability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availability of the draft guidance entitled ``Chemical Indicators 
Premarket Notification [510(k)] Submissions; Draft Guidance for 
Industry and FDA.'' The document is intended to provide guidance for 
industry and other interested parties for the submission of chemical 
indicators such as process indicators, chemical integrators, and air 
removal indicators used in test packs such as the Bowie Dick Test. This 
draft guidance is neither final nor is it in effect at this time.

DATES: Submit written or electronic comments on this guidance by April 
28, 2003.

ADDRESSES:  Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Chemical Indicators 
Premarket Notification [510(k)] Submissions; Draft Guidance for 
Industry and FDA'' 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 two self-addressed labels to assist that 
office in processing your request, or fax your request to 301-443-8818.
    Submit written comments concerning this guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.
    See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the guidance.

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, 301-443-8913, extension 143.

SUPPLEMENTARY INFORMATION:

I. Background

    This document is intended for applicants who plan to market 
chemical indicators for health care facilities. It includes guidance on 
the submission of premarket notification [510(k)] submissions for 
process indicators, chemical integrators, and air removal indicators 
used in test packs such as the Bowie Dick Test. Chemical indicators are 
an integral part of monitoring sterilization processes in health care 
facilities because they provide the user with information on the 
effectiveness of a sterilization process. FDA is issuing this draft 
guidance because the agency recognizes the importance of providing 
applicants and other interested parties with specific recommendations 
for the

[[Page 3888]]

submission of premarket notifications for chemical indicators.

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 
represents the agency's current thinking on chemical indicators. 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

    In order to receive the document ``Chemical Indicators Premarket 
Notification [510(k)] Submissions; Draft Guidance for Industry and 
FDA'' by fax, call the CDRH Facts-On-Demand system at 800-899-0381 or 
301-827-0111 from a touch-tone telephone. Press 1 to enter the system. 
At the second voice prompt press 1 to order a document. Enter the 
document number (1420) followed by the pound sign ([numsign]). Follow 
the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so using the Internet. 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 Dockets Management Branch 
Internet site at http://www.fda.gov/ohrms/dockets.

IV. Comments

    Interested persons may submit to Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this draft 
guidance. Two copies of any mailed comments are to be submitted, except 
that individuals may submit one copy. Identify comments with the docket 
number found in brackets in the heading of this document. The draft 
guidance document and any comments FDA receives may be seen in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: January 9, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-1684 Filed 1-24-03; 8:45 am]
BILLING CODE 4160-01-S