[Federal Register Volume 64, Number 103 (Friday, May 28, 1999)]
[Notices]
[Page 29048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13558]



[[Page 29048]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-1269]


Medical Devices; Draft Guidance on Quality Systems Inspections 
Technique; 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availability of a draft guidance entitled ``Draft Guidance on Quality 
Systems Inspections Technique.'' This draft guidance is intended to 
provide FDA's field staff with a new inspectional method to assess 
medical device manufacturer's compliance with the quality system 
regulation (QSR), which became effective June 1, 1997. This draft 
guidance is also intended to represent the agency's current thinking on 
using a new inspectional technique, and it is neither final nor is it 
in effect at this time.

DATES: Written comments concerning this draft guidance must be 
submitted by August 26, 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electronic access to the draft guidance.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single copies on a 3.5'' diskette of the draft guidance entitled 
``Draft Guidance on Quality Systems Inspections Technique'' to the 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 one self-addressed adhesive 
label 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    Submit written comments on the draft guidance to the Dockets 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:  Tim R. Wells, Center for Devices and 
Radiological Health (HFZ-332), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-594-4616.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Draft Guidance on Quality Systems Inspections Technique.'' This draft 
guidance is intended to provide guidance to the FDA field staff for the 
use of a new inspectional method to assess medical device 
manufacturer's compliance with the QSR (21 CFR part 820). This draft 
guidance is also intended to provide information about an inspectional 
method that uses the seven subsystems of the QSR, which include: (1) 
Corrective and preventive actions, (2) design controls, (3) production 
and process controls, (4) management controls, (5) records/document/
change controls, (6) material controls, and (7) facility/equipment 
controls. The Quality Systems Inspections Technique focuses on the 
first four subsystems as primary indicators of compliance with the QSR.
    This draft guidance represents the agency's current thinking on a 
new method of inspecting medical device manufacturers to assess their 
compliance with QSR. 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 draft guidance is issued as a Level 1 guidance consistent 
with GGP's.

II. Electronic Access

    In order to receive the ``Draft Guidance on Quality Systems 
Inspections Technique'' 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 DMSA Facts, at 
the second voice prompt press 2, and then enter the document number 
(1196) 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 Web. 
Updated on a regular basis, the CDRH home page includes the ``Draft 
Guidance on Quality Systems Inspections Technique,'' 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''. The ``Draft Guidance on Quality Systems 
Inspections Technique'' will be available at ``http://www.fda.gov/cdrh/
gmp/qsitbook.html''.

III. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this draft guidance. Two 
copies of any comments are to be submitted, except individuals may 
submit one copy. Comments should be identified with the docket number 
found in 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: May 17, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-13558 Filed 5-27-99; 8:45 am]
BILLING CODE 4160-01-F