[Federal Register Volume 64, Number 148 (Tuesday, August 3, 1999)]
[Notices]
[Pages 42137-42138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19869]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-2212]


Medical Devices; Draft Guidance on Quality Systems Regulation 
Information for Various Premarket Submissions; 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availability of a draft guidance entitled ``Guidance on Quality System 
Regulation Information for Various PreMarket Submissions.'' This draft 
guidance is intended to assist medical device manufacturers with 
information they should include in premarket approval applications 
(PMA) and product development protocols (PDP) to demonstrate that the 
submissions are in compliance with the revised quality system (QS) 
regulation. This draft guidance document also describes the information 
that should be maintained at the manufacturing facility for premarket 
notifications (510(k)'s). This draft guidance document represents the 
agency's current thinking on the QS regulation information for various 
premarket submissions. This guidance is neither final nor is it in 
effect at this time.
DATES: Written comments concerning this draft guidance must be 
submitted by November 1, 1999.
ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the draft guidance. Submit written requests for 
single copies on a 3.5'' diskette of the draft guidance document 
entitled ``Draft Guidance on Quality System Regulation Information for 
Various PreMarket Submissions'' to the Division of Small Manufacturers 
Assistance (HFZ-220),

[[Page 42138]]

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.
    Submit written comments on the draft guidance to the Dockets 
Management Branch, (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Collin L. Figueroa, Center for Devices 
and Radiological Health (HFZ-341), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-4654.
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Draft Guidance on Quality System Regulation Information for Various 
PreMarket Submissions.'' This draft guidance document is intended to 
describe for manufacturers one means of complying with the requirements 
of the QS regulation in 21 CFR part 820 and the requirement for design 
controls and manufacturing information in various premarket 
submissions.

II. Significance of Guidance

    When used by the premarket applicant in conjunction with the QS 
regulation, this draft guidance document illustrates an approach to 
comply with the content requirements for PMA and PDP submissions in 
section 515(c) of the Food, Drug, and Cosmetic Act (the act) (21 USC 
360e(c)) and 21 CFR part 814. This document also describes the 
information that should be maintained at the manufacturing facility for 
premarket notifications submitted under section 510(k) of the act (21 
U.S.C. 360(k)). The guidance document entitled ``The 510(k) Paradigm: 
Alternate Approaches to Demonstrating Substantial Equivalence in 
Premarket Notifications'' (63 FR 25865, May 11, 1998) describes the 
type of design control information to be submitted in special 510(k)'s 
for device modifications.
    This guidance document 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 draft guidance document is issued as a Level 1 guidance 
consistent with GGPs.

III. Electronic Access

    In order to receive the ``Draft Guidance Document on Quality System 
Regulation Information for Various PreMarket Submissions'' 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 (1140) followed by the pound sign (#). Then 
follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft 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 personal computer with access to the 
WWW. Updated on a regular basis, the CDRH home page includes the 
``Guidance on Quality System Regulation Information for Various 
PreMarket Submissions,'' 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''.

IV. Comments

    Interested persons may, on or before November 1, 1999, submit to 
the Dockets Management Branch (address above) written comments 
regarding this draft 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 foundin brackets in the heading of 
this document. A copy of the draft guidance and received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 20, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-19869 Filed 8-2-99; 8:45 am]
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