[Federal Register Volume 63, Number 57 (Wednesday, March 25, 1998)]
[Proposed Rules]
[Pages 14390-14391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7668]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 801, 803, 804, 806, 807, 810, 820, 821, 1002, and 1020
[Docket No. 97N-0447]
RIN 0910-ZA09
Medical Devices; Review and Revision of Compliance Policy Guides
and Regulatory Requirements for Refurbishers, Rebuilders,
Reconditioners, Servicers and ``As Is'' Remarketers of Medical Devices;
Request for Comments and Information; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking; extension of comment
period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is extending to June
29, 1998, the comment period for the advance notice of proposed
rulemaking (ANPRM) that appeared in the Federal Register of December
23, 1997 (62 FR 67011). This advance notice announced FDA's intention
to review and, as needed, to revise compliance policy guides, amend
regulatory requirements and, as appropriate, exercise alternative
regulatory approaches regarding the remarketing of used medical
devices. The agency is taking this action in response to two requests
for extensions. This extension of comment period is intended to allow
interested persons additional time to submit comments on the ANPRM.
DATES: Written comments by June 29, 1998.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Casper E. Uldriks, Center for Devices
and Radiological Health (HFZ-300), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-4692.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 23, 1997
(62 FR 67011), FDA published an ANPRM announcing the agency's intention
to review and, as needed, to revise compliance policy guides (CPG's),
amend regulatory requirements and, as appropriate, exercise alternative
regulatory approaches with respect to the remarketing of used medical
[[Page 14391]]
devices. This reexamination of device remarketing issues is being
undertaken, in part, because of competing interests and equity concerns
raised by manufacturers, device remarketers, and others, during the
rulemaking process for the agency's Quality System (Q/S) regulation
part 820 (21 CFR part 820). It provides a method of addressing whether,
and to what degree, current good manufacturing practice requirements in
the Q/S regulation should be applied by the agency to firms, other than
manufacturers and remanufacturers, which process and/or remarket
previously used devices outside the control of the device's original
manufacturer.
The agency's reassessment is also being undertaken, in part,
because of FDA's experience in implementing CPG's 7133.20 and 7124.28.
These guides identify what statutory and regulatory requirements, which
control the activities of manufacturers, are applicable to the
activities of firms considered to be x-ray tube reloaders, or device
reconditioners or rebuilders. Agency experience indicates that many
firms are unaware of these compliance guides or their own compliance
responsibilities, or use other terms to describe their activities. The
reassessment is also warranted on the basis of FDA's knowledge of
changes in industry practices in the remarketing of used devices.
As a consequence of the previous factors, and for purposes of
discussion and public comment during the agency's reevaluation of
device remarketing compliance issues, FDA is proposing to define the
activities of device refurbishers, servicers, and ``as is'' remarketers
on the basis that their various activities, in contrast to the
activities of device remanufacturers defined in 21 CFR 820.3(w), do not
significantly change a finished device's performance or safety
specifications, or intended use(s). Having proposed to characterize
such device processing and remarketing activities in this fashion, the
agency is also considering alternative schemes or methods for applying
certain regulatory controls to these activities on a voluntary or
partial basis, or not at all. Comments, proposals for alternative
regulatory schemes, and information were solicited by FDA from the
public, the affected industry and other interested parties, in response
to the ANPRM.
FDA received two requests to extend the comment period. One
requested 30 additional days to focus resources on the referenced
matter. The other requested an extension of 180 days so that issues may
be discussed further at the multi-day conference of a device industry
association, scheduled for September 1998.
FDA believes there is good cause to extend the comment period.
However, FDA believes that a 180-extension period would unduly delay
the process. Therefore, FDA is extending the comment period for 90
additional days.
Interested persons may, on or before June 29,1998, submit to the
Dockets Management Branch (address above) written comments regarding
the December 23, 1997, ANPRM described above. 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 office above between 9 a.m. and 4 p.m., Monday through Friday.
Dated: March 4, 1998.
D. B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-7668 Filed 3-24-98; 8:45 am]
BILLING CODE 4160-01-F