[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]
-----------------------------------------------------------------------
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Medical Devices; Draft Guidance on Quality Systems Regulation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.
-----------------------------------------------------------------------
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availability of a draft guidance entitled ``Guidance on Quality System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 This draft
guidance is intended to assist medical device manufacturers with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 This draft guidance document also describes the information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 This draft guidance document represents the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DATES: Written comments concerning this draft guidance must be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electronic access to the draft guidance.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single copies on a 3.5'' diskette of the draft guidance document
entitled ``Draft Guidance on Quality System Regulation Information for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Submit written comments on the draft guidance to the Dockets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]
BILLING CODE 4160-01-F