[Federal Register Volume 66, Number 245 (Thursday, December 20, 2001)]
[Notices]
[Pages 65723-65724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31334]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01D-0514]
Medical Devices; Guidance on Labeling of Reprocessed Single Use
Devices; Request for Comments and Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is providing an
opportunity for interested persons to submit comments and suggestions
on the contents of a guidance document that FDA is considering drafting
on the labeling of reprocessed single use devices (SUDs) with respect
to the name of the original equipment manufacturer (OEM) and the
remanufacturer (i.e., reprocessor). FDA is publishing this notice in
order to gather informed comment before drafting the guidance.
DATES: Submit written or electronic comments or suggestions by March
20, 2002.
ADDRESSES: Submit written comments and information to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
http:// www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Larry Spears, Center for Devices and
Radiological Health (HFZ-300), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 301-594-4692.
SUPPLEMENTARY INFORMATION:
I. Background
In a citizen petition, dated March 22, 2001, the Association of
Disposable Device Manufacturers (ADDM) requested that FDA: (1) Require
reprocessors of SUDs (hereinafter referred to as reprocessed devices)
to remove the OEM trademark from the devices and any references to the
OEM in the label of devices; (2) take actions to identify and enforce
this requirement; and (3) refuse to approve premarket submissions
unless the applicant represents that the device will meet this
requirement.
On September 17, 2001, FDA issued a response to this petition. FDA
denied the petition because FDA believed that misleading implications
from representations concerning the OEM may be remedied by the
disclosure of
[[Page 65724]]
additional facts about the remanufacturer. Specifically, FDA stated:
FDA, however, does believe that representations concerning the
OEM may be misleading unless the reprocessor of a single use device
provides additional information that would indicate that the
reprocessor is the manufacturer responsible for product problems. As
you note in your petition, hospitals and other user facilities must
alert FDA or the manufacturer whenever there is information that
``reasonably suggests that a device has or may have caused or
contributed to the death ... [or] serious injury to a patient ...''
21 CFR 803.30(a). Moreover, the user or FDA may need to know the
identity of the manufacturer, not only for the purposes of reporting
adverse events to FDA, but to assure that the responsible
manufacturer or FDA can investigate the problem to determine if
additional steps should be taken, including distribution of safety
information to the users, or product recalls. Accordingly, FDA
believes that when a reprocessed product's labeling makes
representations that suggest the OEM should be notified of product
problems, additional information that provides the correct identity
of the reprocessor as the remanufacturer who is responsible for
adverse event reporting, recalls, or other corrective actions, is
``material'' information within the meaning of section 201(n) of the
Act because such information is necessary to enable FDA's postmarket
reporting procedures under section 519 of the Act to function
effectively.
In the response to the petition, FDA also said that it would
publish a guidance document that will recommend more specific language
and direction to regulated industry on this matter. Before it develops
this guidance document, FDA is inviting interested persons to submit
comments and suggestions on the contents of such a guidance.
The ADDM petition and FDA's response are available from the Dockets
Management Branch (address above). Please reference Docket No. 01P-
0148.
II. Comments
Interested persons may submit to the Dockets Management Branch
(address above) written or electronic comments or suggestions regarding
this issue by March 20, 2002. 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. Received comments may be seen in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: November 28, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 01-31334 Filed 12-19-01; 8:45 am]
BILLING CODE 4160-01-S