[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