[Federal Register Volume 65, Number 39 (Monday, February 28, 2000)]
[Notices]
[Pages 10502-10503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4662]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Medical Device Quality Systems Inspection Technique; Notice of 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a 
workshop on the FDA Quality System Inspection Technique (QSIT). The 
topics to be discussed include: The development of QSIT, compliance 
program and warning letter pilot, management controls, corrective and 
preventative actions, design controls, production and process controls, 
and industry perspective of QSIT. The purpose of this QSIT workshop is 
to increase understanding of QSIT in the medical device community. By 
explaining this new inspection technique, FDA intends to ensure that 
the medical device industry takes appropriate action to establish 
effective quality systems and to prevent regulatory problems when 
inspections occur.
    Date and Time: The workshop will be held on March 8, 2000, from 
8:30 a.m. to 4:30 p.m.
    Location: The workshop will be held at the Condado Plaza Hotel, 999 
Ashford Ave., San Juan, PR 00907.
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number) along with a 
registration fee of $125.00 to Jose P. Rodriguez, Director of Special 
Programs and Seminars, the Puerto Rico Manufacturers Association, P.O. 
Box 195477, San Juan, PR 00919-

[[Page 10503]]

5477, 787-759-9445, ext. 204, FAX 787-756-7670. The fee covers 
refreshments, organization and site costs, and materials. Space is 
limited; therefore interested parties are encouraged to register early. 
Please arrive early to ensure prompt registration.
    If you need special accommodations due to a disability, please 
inform Jose P. Rodriguez (address above) at least 7 days in advance of 
the workshop.
    Contact: H. Gordon Cox, Supervisory Investigator, FDA San Juan 
District Office, 466 Fernandez Juncos Ave., San Juan, PR 787-729-6801.

SUPPLEMENTARY INFORMATION: In the fall of 1999, the FDA field offices 
began using QSIT nationwide as the primary tool for medical device good 
manufacturing practice/quality system (GMP/QS) inspections. QSIT was 
developed using a collaborative effort with stakeholders, and it was 
tested in three districts.
    The workshop helps to implement the objectives of section 406 of 
the FDA Modernization Act (21 U.S.C. 393) and the FDA Plan for 
Statutory Compliance, which includes working more closely with 
stakeholders and ensuring access to needed scientific and technical 
expertise.
    The workshop is also consistent with the Small Business Regulatory 
Enforcement Fairness Act (Public Law 104-121) by providing outreach 
activities directed to small businesses.

    Dated: February 23, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-4662 Filed 2-23-00; 4:20 pm]
BILLING CODE 4160-01-F