[Federal Register Volume 65, Number 22 (Wednesday, February 2, 2000)]
[Notices]
[Pages 4985-4986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2244]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-0053]


Draft Guidance on Reprocessing and Reuse of Single-Use Devices: 
Risk Categorization Scheme; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Reprocessing and Reuse of 
Single-Use Devices: Risk Categorization Scheme.'' This draft guidance 
is not final nor is it in effect at this time. This document is 
intended to provide draft guidance for categorizing the risks posed by 
single-use devices (SUD's) that are reprocessed and/or reused. FDA may 
use this scheme to set enforcement priorities for regulation of 
reprocessed and/or reused SUD's.

DATES:  Submit written comments concerning this draft guidance by March 
3, 2000.

ADDRESSES:  See the SUPPLEMENTARY INFORMATION section for information 
on electronic access to the draft guidance. Submit written requests for 
single copies on a 3.5" diskette of the draft guidance document 
entitled ``Reprocessing and Reuse of Single-Use Devices: Risk 
Categorization Scheme'' 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    Submit written comments concerning this draft guidance to the 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. Comments should be 
identified with the docket number found in brackets in the heading of 
this document.

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

[[Page 4986]]


SUPPLEMENTARY INFORMATION:

I. Background

    Reuse of SUD's is the practice of cleaning, disinfecting, 
sterilizing, and reusing medical devices that are intended for only one 
use. Reuse has raised concerns regarding patient safety, informed 
consent, and equitable regulation of reuse under the Federal Food, Drug 
and Cosmetic Act. On May 5 and 6, 1999, FDA and the Association for the 
Advancement of Medical Instrumentation cosponsored a conference on 
reuse of single-use devices to help examine policy alternatives 
regarding the practice of reuse. As a result of that meeting, FDA made 
the draft guidance entitled ``FDA's Proposed Strategy on Reuse of 
Single-Use Devices'' available on November 3, 1999. Risk categorization 
of SUD's was one topic of discussion at an open meeting held by FDA on 
December 14, 1999. This document was the basis for the discussion at 
that meeting and is now being made more widely available for public 
comment. FDA expects to issue an updated draft of this guidance shortly 
and will also make that draft available for public comment.

II. Significance of Guidance

    This draft guidance document represents the agency's current 
thinking on the categorization of risk for SUD's. 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, regulations, or both.
    The agency has adopted Good Guidance Practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This guidance document is issued as a Level 1 guidance 
consistent with GGP's.

III. Electronic Access

    In order to receive the draft guidance entitled ``Reprocessing and 
Reuse of Single-Use Devices: Risk Categorization Scheme'' via your fax 
machine, call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 
301-827-0111 from a touch-tone telephone. At the first voice prompt 
press 1 to access DSMA Facts, at second voice prompt press 2, and then 
enter the document number 1156 followed by the pound sign (#). Then 
follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the 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. Updated on a regular basis, the CDRH 
home page includes ``Reprocessing and Reuse of Single-Use Devices: Risk 
Categorization Scheme,'' 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. ``Reprocessing and Reuse of Single-Use Devices: Risk 
Categorization Scheme'' will be available at http://www.fda.gov/cdrh/Reuse.

IV. Comments

    Interested persons may, on or before May 2, 2000, submit to Dockets 
Management Branch (address above) written comments regarding this draft 
guidance. 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 
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: January 23, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-2244 Filed 2-1-00; 8:45 am]
BILLING CODE 4160-01-F