[Federal Register Volume 63, Number 103 (Friday, May 29, 1998)]
[Proposed Rules]
[Pages 29364-29365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14049]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 820


Quality System Inspection Technique Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
following public meeting: ``Quality System Inspection Technique.'' The 
goal of the meeting is to obtain views and opinions from interested 
parties concerning a proposed new technique for conducting quality 
system inspections. This proposed technique could eventually replace 
the technique presently used when FDA conducts quality systems (good 
manufacturing practices) inspections of medical device manufacturers. 
The proposed ``Quality System Inspection Technique'' was developed by a 
group composed of the Center for Devices and Radiological Health (CDRH) 
and Office of Regulatory Affairs staff, familiar with the Quality 
Systems Regulation and present inspectional processes, with input from 
the medical device industry. This meeting is part of the CDRH's ongoing 
reengineering effort to develop an inspection program covering the 
Quality System Regulation that results in more focused and efficient 
inspections.
DATES:  The public meeting will be held on Thursday, June 18, 1998, 
from 8:30 a.m. to 5 p.m.
ADDRESSES:  The public meeting will be held at 5600 Fishers Lane, 
conference rooms D and E, third floor, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: 
    For information regarding the meeting: Timothy R. Wells, Center for 
Devices and Radiological Health (HFZ-332), 2094 Gaither Rd., Rockville, 
MD 20859, 301-594-4616, FAX 301-594-4638, e-mail <a href="/cdn-cgi/l/email-protection#e6929491a68582948ec8808287c8818990"><span class="__cf_email__" data-cfemail="f7838580b79493859fd9919396d9909881">[email protected]</span></a>.
    For information regarding registration or requests for oral 
presentations: Georgia A. Layloff, Food and Drug Administration, St. 
Louis Branch Office, 12 Sunnen Dr., suite 122, St. Louis, MO 63143, 
314-645-1167, ext. 121, FAX 314-645-2969, e-mail <a href="/cdn-cgi/l/email-protection#37505b564e5b585151775845561951535619505841"><span class="__cf_email__" data-cfemail="30575c51495c5f5656705f42511e5654511e575f46">[email protected]</span></a>.
 SUPPLEMENTARY INFORMATION:  The draft entitled ``Quality System 
Inspection Technique'' is posted for comment on the CDRH's World Wide 
Web (www) home page. The draft document may be

[[Page 29365]]

accessed at http://www.fda.gov/cdrh/gmp/gmp.html.
    Send registration information (including name, title, firm name, 
address, telephone, and fax number), and written material and requests 
to make oral presentations, to the contact person by June 11, 1998. No 
telephone requests will be accepted. You will be notified by fax to 
tell whether your presentation will be included and your time 
limitation. If you cannot be reached by fax, please note that in your 
request.
    Due to space limitations, interested parties are encouraged to 
register early. Depending on the number of requests, registration may 
be limited to one representative per firm or organization. If special 
accommodations are needed due to a disability, please contact Timothy 
R. Wells, at least 7 days in advance.

    Dated: May 19, 1998.
Linda S. Kahan,
Acting Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 98-14049 Filed 5-28-98; 8:45 am]
BILLING CODE 4160-01-F


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