[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]
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