[Federal Register Volume 64, Number 199 (Friday, October 15, 1999)]
[Pages 55946-55947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26804]



Food and Drug Administration

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 
    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.
    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
                                               Deadline to Register      Registrar and
   Workshop Address     Date and Local Time          and Fee               Cosponsor         FDA Contact Person
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.

    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:


[[Page 55947]]


    Dated: October 6, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-26804 Filed 10-14-99; 8:45 am]