[Federal Register Volume 63, Number 212 (Tuesday, November 3, 1998)]
[Notices]
[Pages 59316-59317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29389]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0108]


SMDA to FDAMA: Guidance on FDA's Transition Plan for Existing 
Postmarket Surveillance Protocols; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``SMDA to FDAMA: Guidance on 
FDA's Transition Plan for Existing Postmarket Surveillance Protocols.'' 
This guidance is for industry and FDA staff. This document indicates 
the agency's intent to terminate or continue postmarket surveillance 
(PS) orders for existing products and describes the criteria used to 
reach these determinations.

DATES: Written comments may be submitted at anytime.

ADDRESSES: Submit written comments on ``SMDA to FDAMA: Guidance on 
FDA's Transition Plan for Existing Postmarket Surveillance Protocols'' 
to the contact person. Submit written

[[Page 59317]]

requests for single copies on a 3.5'' diskette of the guidance document 
entitled ``SMDA to FDAMA: Guidance on FDA's Transition Plan for 
Existing Postmarket Surveillance Protocols'' to the Division of Small 
Manufacturers Assistance (HFZ-220), Center for Devices and 
Radiological, 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.

FOR FURTHER INFORMATION CONTACT: Laura A. Alonge, Center for Devices 
and Radiological Health (HFZ-543), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-0648.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Safe Medical Devices Act (the SMDA) of 1990, FDA had 
implemented required PS (RPS) for 17 category ``A'' devices (permanent 
implants the failure of which could result in death or serious injury) 
and one category ``C'' device (plasma sprayed porous coated hips). In 
addition, the discretionary PS (DPS) authority under the SMDA had been 
used to order studies of a number of devices. The FDA Modernization Act 
(FDAMA) of 1997 (Pub. L. 105-115) has significantly modified the 
requirements for PS under section 522 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360l). Under FDAMA, PS may be ordered only for 
those devices that are Class II or Class III the failure of which would 
be reasonably likely to have serious adverse health consequences or 
which is intended to be: (1) Implanted in the human body for more than 
1 year, or (2) [is] life sustaining or life supporting and used outside 
a device user facility. The draft of this guidance was made available 
for comment on February 25, 1998. FDA received comments from three 
sources. General comments were supportive of the criteria used to make 
the determinations contained in the guidance and urged that 
manufacturers of devices for which PS orders would be rescinded be 
notified as quickly as possible. FDA agrees with these comments as well 
as comments related to three specific devices: Replacement heart valve, 
implantable cardioverter-defibrillator (ICD), and plasma-sprayed porous 
coated hip. The guidance for replacement heart valves and ICD's has 
been revised accordingly. The comments on the plasma-sprayed porous 
coated hip did not affect the guidance, but will be considered in the 
evaluation of each existing protocol for continuation or termination of 
PS requirements.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
the disposition of existing PS protocols. 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.

III. Electronic Access

    In order to receive ``SMDA to FDAMA: Guidance on FDA's Transition 
Plan for Existing Postmarket Surveillance Protocols'' 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 318 followed by the pound sign (#). Then 
follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance 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 personal computer with access to the WWW. 
Updated on a regular basis, the CDRH home page includes ``SMDA to 
FDAMA: Guidance on FDA's Transition Plan for Existing Postmarket 
Surveillance Protocols,'' 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''. ``SMDA to FDAMA: Guidance on FDA's Transition Plan 
for Existing Postmarket Surveillance Protocols'' will be available at 
``http://www.fda.gov/cdrh/modact/modguide.html''.

IV. Comments

    Interested persons may, at any time, submit to the contact person 
(address above) written comments regarding this guidance. Such comments 
will be considered when determining whether to amend the current 
guidance. 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. 98-29389 Filed 11-2-98; 8:45 am]
BILLING CODE 4160-01-F