[Federal Register Volume 64, Number 212 (Wednesday, November 3, 1999)]
[Notices]
[Pages 59782-59783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28807]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-4491]


FDA's Proposed Strategy on Reuse of Single Use Devices; 
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 a document entitled ``FDA's Proposed Strategy on Reuse 
of Single-Use Devices.'' The document presents the agency's current 
thinking about the best way to address the concerns regarding the 
practice of reprocessing and reusing devices that are labeled, or 
otherwise intended, for one use only (referred to as ``single use 
devices'' (SUD's)). The strategy outlined in the document is based, in 
part, on information and suggestions the agency received during the May 
5 and 6, 1999, conference on Reuse of Single-Use Devices, which the 
agency cosponsored with the Association for the Advancement of Medical 
Instrumentation (AAMI). The document reflects FDA's belief that the 
optimum approach to this issue will involve action by the agency and 
all of the affected stakeholders. The agency is soliciting comments, 
proposals for alternative approaches, and information on this issue. In 
a future issue of the Federal Register, the agency will announce an 
open meeting, to be held

[[Page 59783]]

in Rockville, Maryland on December 14, 1999, to gather comments on the 
agency's proposed strategy.

DATES: Submit written comments at anytime.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the document. Submit written requests for single 
copies (on a 3.5'' diskette) of ``FDA's Proposed Strategy on 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. Submit written comments 
concerning ``FDA's Proposed Strategy on Reuse of Single-Use Devices'' 
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: Larry D. Spears, Center for Devices 
and Radiological Health (HFZ-340), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-594-4646.

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 AAMI cosponsored 
a conference on Reuse of Single-Use Devices to help examine policy 
alternatives regarding the practice of reuse. At that time, the agency 
committed to publishing a response to the positions expressed at the 
conference in the Federal Register by no later than October 1999. 
``FDA's Proposed Strategy on Reuse of Single-Use Devices'' is that 
response.

II. Significance of the Proposed Strategy Document

    ``FDA's Proposed Strategy on Reuse of Single-Use Devices'' 
represents options that the agency is considering on the reuse of 
single-use devices.

III. Electronic Access

    In order to receive ``FDA's Proposed Strategy on 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. At 
the first voice prompt press 1 to access DSMA Facts, at the second 
voice prompt press 2, and then enter the document number 2525 followed 
by the pound sign (). Then follow the remaining voice prompts to 
complete your request.
    Persons interested in obtaining a copy of ``FDA's Proposed Strategy 
on Reuse of Single-Use Devices'' 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 ``FDA's Proposed Strategy on Reuse 
of Single-Use Devices,'' 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.

IV. Comments

    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments regarding this 
document. Submit two copies of any comments, except that individuals 
may submit one copy. Comments should be identified with the docket 
number found in brackets in the heading of this document. The agency 
will consider such comments when determining their final strategy. 
``FDA's Proposed Strategy on Reuse of Single-Use Devices'' and any 
received comments may be seen in the Dockets Management Branch between 
9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 28, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-28807 Filed 11-1-99; 12:19 pm]
BILLING CODE 4160-01-F