[Federal Register Volume 64, Number 199 (Friday, October 15, 1999)]
[Notices]
[Pages 55946-55947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26804]
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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; Public Workshops;
Addendum
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA), is announcing an
additional workshop in the series of FDA/Industry Exchange Workshops
being conducted. The original list of workshops was published in the
September 10, 1999 Federal Register. Topics for discussion include:
Development of QSIT, Compliance Program and Warning Letter (Pilot),
Management Controls, Corrective and Preventive Action, Design Controls,
and Industry Perspective of 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, Time, and Location: The workshop will be held on November 30
from 8:30 a.m. to 4:30 p.m. local time in Englewood, CO at the location
in the chart below.
Registration: Send registration information (including name, title,
firm name, address, telephone, and fax number) along with the correct
payment amount to the Registrar. Fees cover 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 accomodations due to a
disability, please inform the Registrar at least 7 days in advance of
the workshop. A sample registration form is provided at the end of this
document.
Contact Person: Herman B. Janiger, U.S. Food and Drug
Administration, Northeast Region, (HFRNE-17), 850 Third Ave., Brooklyn,
New York 11232, 718-340-7000 ext. 5528.
SUPPLEMENTARY INFORMATION:
In the fall of 1999, FDA field offices will begin using the QSIT
natiowide as the primary tool for medical device inspections. QSIT was
developed using a collaborative effort with stakeholders and tested in
the three districts. The additional workshop is scheduled as follows:
Table 1
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Deadline to Register Registrar and
Workshop Address Date and Local Time and Fee Cosponsor FDA Contact Person
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ENGLEWOOD: Hilton Tuesday, November 30, Tuesday, November 16, Denise Rooney, Brenda C. Baumert,
Hotel, Denver Tech 1999, 8:30 a.m. to 1999, $170.00 Association of Food Small Business
Center South, 7801 4:30 p.m. and Drug Officials, Representative,
Orchard Rd., P.O. Box 3425, York Southwest Regional
Englewood, CO 303- PA 17402, 717-757- Office, 214-655-
779-6161. 2888, FAX 717-755- 810, ext. 133.
8089
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The above 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
complies with the Small Business Regulatory Enforcement Fairness Act
(Public Law 104-121) that requires outreach activities by Government
agencies directed to small businesses. This notice announcing the
workshops and a registration form may also be accessed at the CDRH
website at http://www.fda.gov/cdrh/fedregin.html. The following
information is requested for registration:
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[GRAPHIC] [TIFF OMITTED] TN15OC99.000
Dated: October 6, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-26804 Filed 10-14-99; 8:45 am]
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