[Federal Register Volume 65, Number 48 (Friday, March 10, 2000)]
[Notices]
[Page 13010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5835]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Food and Drug Administration/Industry Exchange Workshop on 
Medical Device Quality Systems Inspection Technique (QSIT); Public 
Workshops; Addendum

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA) is announcing an additional 
workshop in the series of FDA/Industry Exchange Workshops that were 
conducted in 1999. The original list of workshops was published in the 
Federal Register of September 10, 1999. Topics for discussion include: 
Development of Quality Systems Inspection Technique (QSIT), Compliance 
Program and Warning Letter (Pilot), Management Controls, Corrective and 
Preventive Action, Design Controls, and Industry Perspective QSIT. This 
additional workshop will enhance the medical device community's 
understanding of QSIT, and the device industry's establishment of 
effective quality systems, thereby preventing regulatory problems 
during inspections.
    Date and Time: The meeting will be held on Wednesday, March 29, 
2000, 8:30 a.m. to 4:30 p.m.
    Location: The meeting will be held at Carlsbad: Four Seasons 
Resort--Aviara, 7100 Four Seasons Point, Carlsbad, CA 92009, 760-603-
6800.
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number) along with $140 to the 
registrar by Monday, March 20, 2000. Fees cover refreshments, 
organization and site cost, 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 the registrar at least 7 days in 
advance of the workshop. A sample registration form is provided at 
http://www.fda.gov/cdrh/meetings/qsitmeetca.html.
    Contact: Marcia Madrigal, FDA, Pacific Region (HFR PA-150), 1301 
Clay St., suite 1180-N, Oakland, CA 94612-5217, 510-637-3980.
    Registrar and cosponsor: Joyce W. Williams, San Diego Regulatory 
Affairs Network (SDRAN), c/o Arena Pharmaceuticals, Inc., 6166 Nancy 
Ridge Dr., San Diego, CA 92121, 858-453-7200, ext. 227, FAX 858-453-
7210, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: In the fall of 1999, FDA field offices began 
using the QSIT nationwide as the tool for medical device inspections. 
QSIT was developed using a collaborative effort with stakeholders and 
tested in the three districts. The original list of workshops was 
published in the Federal Register of September 10, 1999 (64 FR 49192).
    This additional workshop further implements the FDA Plan for 
Statutory Compliance (developed under section 406 of the FDA 
Modernization Act (21 U.S.C. 393)) through working more closely with 
stakeholders and ensuring access to needed scientific and technical 
expertise. It also implements a Small Business Regulatory Enforcement 
Fairness Act (Public Law 104-121) goal of providing outreach activities 
by Government agencies directed to small businesses.

    Dated: March 6, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-5835 Filed 3-9-00; 8:45 am]
BILLING CODE 4160-01-F