[Federal Register Volume 63, Number 212 (Tuesday, November 3, 1998)]
[Notices]
[Pages 59315-59316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29390]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0672]
Guidance on Criteria and Approaches for Postmarket Surveillance;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
[[Page 59316]]
availability of a guidance document entitled ``Guidance on Criteria and
Approaches for Postmarket Surveillance.'' This guidance document
provides examples of the agency's criteria and approaches for
determining which products may be subject to postmarket surveillance
(PS) under the Food and Drug Administration Modernization Act of 1997
(FDAMA). In developing this guidance document, the agency considered
comments received from consumer, clinical, and industry representatives
at a public meeting on changes in medical device tracking and PS
authority on January 15, 1998, in Gaithersburg, MD. To facilitate
conformance with the requirements under FDAMA, this guidance document
is immediately in effect.
DATES: Written comments concerning the guidance document entitled
``Guidance on Criteria and Approaches for Postmarket Surveillance''
must be received by February 1, 1999. After February 1, 1999, you may
submit written comments on the guidance document to the contact person
listed below.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Guidance on Criteria and Approaches for Postmarket
Surveillance'' on a 3.5'' diskette 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. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance document.
Submit written comments regarding this guidance document 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: Anita M. Rayner, Center for Devices
and Radiological Health (HFZ-543), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-0639.
SUPPLEMENTARY INFORMATION:
I. Background
The Safe Medical Devices Act of 1990 amended the Federal Food,
Drug, and Cosmetic Act (the act), among other things, to add section
522 (21 U.S.C. 360l) to require PS for certain medical devices. Section
522 of the act was further amended by FDAMA (Pub. L. 105-115). As
amended, section 522 of the act revises the criteria for determining
which devices are subject to PS and revises the procedures for
implementing PS. The revised provisions of section 522 of the act
became effective on February 19, 1998. FDA is making this guidance
document available at this time in order to facilitate the initial
implementation of the revised PS provisions.
This guidance document represents the agency's current thinking on
criteria and approaches for PS. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
applicable statute, regulations, or both.
The agency has adopted good guidance practices (GGP's), which set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). This guidance document is issued as a Level 1 guidance
consistent with GGP's. This document is for immediate implementation to
facilitate conformance with PS changes in section 522 of the act under
FDAMA.
II. Electronic Access
In order to receive the guidance document entitled ``Guidance on
Criteria and Approaches for Postmarket Surveillance'' via your fax
machine, call the CDRH Facts-On-Demand (FOD) 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 second voice prompt press 2, and then
enter the document number (009) followed by the pound sign (#). Then
follow the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the guidance document may
also do so using the World Wide Web (WWW). CDRH maintains an entry on
the WWW for easy access to information including text, graphics, and
files that may be downloaded to a PC with access to the Web. Updated on
a regular basis, the CDRH home page includes ``Guidance on Criteria and
Approaches for Postmarket Surveillance,'' 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''.
III. Comments
Interested persons may, on or before February 1, 1999, submit to
Dockets Management Branch (address above) written comments regarding
the guidance document. After February 1, 1999, submit to the contact
person (address above) written comments regarding the guidance
document. Such comments will be considered when determining whether to
amend the current guidance document. 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. The guidance document and received comments
may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: October 28, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-29390 Filed 11-2-98; 8:45 am]
BILLING CODE 4160-01-F
