[Federal Register Volume 67, Number 45 (Thursday, March 7, 2002)]
[Notices]
[Page 10418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-5489]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0039]


Medical Devices; Draft Guidance for Industry and FDA on Premarket 
Notification Submissions for Medical Sterilization Packaging Systems in 
Health Care Facilities; 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availability of the draft guidance entitled ``Premarket Notification 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 Sterilization Packaging Systems in 
Health Care Facilities; Draft Guidance for Industry and FDA.'' This 
document provides guidance concerning the content and format of 510(k) 
submissions for medical sterilization packaging systems intended for 
the sterilization of medical devices in health care facilities. This 
guidance is neither final nor is it in effect at this time.

DATES: Submit written or electronic comments on the draft guidance by 
June 5, 2002. General comments on agency guidance documents are welcome 
at any time.

ADDRESSES: Submit written requests for single copies on a 3.5 diskette 
of the draft guidance entitled ``Premarket Notification [510(k)] 
Submissions for Medical Sterilization Packaging Systems in Health Care 
Facilities; Draft Guidance for Industry and FDA'' to the Division of 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. Comments should be identified with 
the docket number found in brackets in the heading of this document. 
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.

SUPPLEMENTARY INFORMATION:

I. Background

    Medical sterilization packaging systems encompass sterilization 
wrap, sterilization pouches or packages, sterilization containers, 
trays, cassettes, including mats, holders, or any other related 
component that is used for sterilization of medical devices. These 
devices are class II devices, regulated under 21 CFR 880.6850. The 
draft guidance provides advice on the kind of information and data 
needed to demonstrate the substantial equivalence of a medical 
sterilization packaging system device.

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 ``Premarket Notification 
[510(k)] Submissions for Medical Sterilization Packaging Systems in 
Health Care Facilities; Draft Guidance for Industry and FDA.'' 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 draft guidance entitled ``Premarket 
Notification [510(k)] Submissions for Medical Sterilization Packaging 
Systems in Health Care Facilities; Draft Guidance for Industry and 
FDA'' via your fax machine, 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 (1388) followed by the pound sign 
(#). 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 the civil money penalty 
guidance documents package, device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH home page 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 at http://www.fda.gov/ohrms/dockets.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments regarding this draft 
guidance by June 5, 2002. 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 document and received comments may 
be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: February 26, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-5489 Filed 3-6-02; 8:45 am]
BILLING CODE 4160-01-S