[Federal Register Volume 66, Number 245 (Thursday, December 20, 2001)]
[Pages 65723-65724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31334]



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.


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.


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 
    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 
    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-

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]