[Federal Register Volume 66, Number 98 (Monday, May 21, 2001)]
[Notices]
[Page 27985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12624]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0193]


Medical Devices Premarket Notifications [510(k)] for Biological 
Indicators Intended to Monitor Sterilizers Used in Health Care 
Facilities; Draft Guidance for Industry and FDA Reviewers; Availability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availability of the draft guidance entitled ``Premarket Notifications 
[510(k)] for Biological Indicators Intended to Monitor Sterilizers Used 
in Health Care Facilities; Draft Guidance for Industry and FDA 
Reviewers.'' This draft guidance document provides specific 
recommendations on data and information medical device manufacturers 
should submit in premarket notifications (510(k)s) for biological 
indicators intended to monitor sterilizers used in health care 
facilities. This draft guidance is neither final nor is it in effect at 
this time.

DATES: Submit written comments on the draft guidance by August 20, 
2001.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft guidance document entitled ``Premarket Notifications 
[510(k)] for Biological Indicators Intended to Monitor Sterilizers Used 
in Health Care Facilities; Draft Guidance for Industry and FDA 
Reviewers'' to the Division of Small Manufacturers Assistance (HFZ-
220), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-
addressed adhesive labels to assist that office in processing your 
request, or fax your request to 301-443-8818. Submit written comments 
concerning this draft guidance to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

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

    FDA regulates biological indicators intended to monitor sterilizers 
used in health care facilities as class II medical devices, requiring 
premarket notification (510(k)). The effective performance of 
sterilizers used in health care facilities is important to prevent 
nosocomial infections. Biological indicators provide users with 
information on the effectiveness of the sterilization process. This 
draft guidance document recommends the kind of data and information you 
should submit in a 510(k) for these devices. The use of comprehensive, 
scientifically sound review criteria helps ensure the safety and 
effectiveness of these devices. FDA recognizes that providing FDA 
reviewers, 510(k) applicants, and other interested parties information 
on its review process can promote a consistent and efficient regulatory 
process.

II. Significance of Guidance

    This draft guidance document represents the agency's current 
thinking on premarket notifications (510(k)) for biological indicators 
intended to monitor sterilizers used in health care facilities. 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 applicable statute and regulations.
    The agency has adopted good guidance practices (GGPs), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (21 CFR 10.115; 65 FR 56468, 
September 19, 2000). This draft guidance document is issued as a Level 
1 guidance consistent with the GGP regulations.

III. Electronic Access

    In order to receive ``Premarket Notifications [510(k)] for 
Biological Indicators Intended to Monitor Sterilizers Used in Health 
Care Facilities; Draft Guidance for Industry and FDA Reviewers'' 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 (1320) 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 access to the Internet. 
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. ``Premarket Notifications [510(k)] for Biological Indicators 
Intended to Monitor Sterilizers Used in Health Care Facilities; Draft 
Guidance for Industry and FDA Reviewers'' is also available at http://www.fda.gov/cdrh/ode/guidance/1320.pdf. Guidance documents are also 
available on the Dockets Management Branch Web site at http://www.fda.gov/ohrms/dockets/default.htm.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this draft guidance by 
August 20, 2001. Submit two copies of any comments, 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: May 8, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-12624 Filed 5-18-01; 8:45 am]
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