[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]


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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.

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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