[Federal Register Volume 66, Number 106 (Friday, June 1, 2001)]
[Notices]
[Pages 29822-29823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13731]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0232]


Medical Devices Premarket Guidance: Reprocessing and Reuse of 
Single-Use Devices; Draft Guidance for Industry and FDA Staff; 
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availability of the draft guidance entitled ``Premarket Guidance: 
Reprocessing and Reuse of Single-Use Devices.'' This draft guidance 
document provides premarket guidance to the medical device industry, 
including third party and hospital reprocessors, and to Center for 
Devices and Radiological Health (CDRH) staff, who are responsible for 
the premarket evaluation of submissions for reprocessed single-use 
devices (SUDs) or related enforcement activities. This draft guidance 
is neither final nor is it in effect at this time.

DATES: Submit written comments on the draft guidance by August 30, 
2001.

ADDRESSES:  Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled, ``Premarket Guidance: 
Reprocessing and Reuse of Single-Use Devices'' 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. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance document.

FOR FURTHER INFORMATION CONTACT: Tim Ulatowski, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8879.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 14, 2000 (65 FR 49583), FDA 
published a final guidance entitled ``Enforcement Priorities for 
Single-Use Devices Reprocessed by Third Parties and Hospitals'' (``the 
Enforcement Priorities document''). The Enforcement Priorities document 
provides guidance to third parties and hospital reprocessors about 
their responsibilities as manufacturers engaged in reprocessing devices 
labeled for SUDs under the Federal Food, Drug, and Cosmetic Act. This 
draft guidance document entitled ``Premarket Guidance: Reprocessing and 
Reuse of Single-Use Devices,'' expands upon the summary premarket 
information in the Enforcement Priorities document.

II. Significance of Guidance

    This draft guidance document represents the agency's current 
thinking on policies and recommendations regarding premarket regulatory 
and technical issues for reprocessed SUDs. 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

[[Page 29823]]

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 in accordance with the GGP regulations.

III. Electronic Access

    In order to receive ``Premarket Guidance: Reprocessing and Reuse of 
Single-Use Devices'' 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 (1331) 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. Guidance documents are also available on the Dockets Management 
Branch Internet site at http://www.fda.gov/ohrms/dockets/default.htm.

IV. Comments

    Interested persons may submit to Dockets Management Branch (address 
above) written comments regarding this draft guidance by August 30, 
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 22, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-13731 Filed 5-31-01; 8:45 am]
BILLING CODE 4160-01-S