[Federal Register Volume 64, Number 219 (Monday, November 15, 1999)]
[Notices]
[Pages 61878-61880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29630]


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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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SUMMARY: The Food and Drug Administration (FDA), is announcing 
additional workshops in the series of FDA/Industry Exchange Workshops. 
The original list of workshops was published in the Federal Register of 
September 10, 1999. Topics for discussion at these workshops include: 
Development of QSIT, Compliance Program and Warning Letter (Pilot), 
Management Controls, Corrective and Preventive Action, Design Controls, 
and Industry Perspective of QSIT. These additional workshops 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: See Table 1 in the Supplementary 
Information section of this document.
    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. Because space is limited, 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 the end of this 
document.
    Contact Person: Herman B. Janiger, 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 
nationwide as

[[Page 61879]]

the primary tool for medical device inspections. QSIT was developed 
using a collaborative effort with stakeholders and was tested in the 
three districts. The additional workshops are 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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Costa Mesa: Wyndham    Tuesday, November 16,  Friday, November 12,   PeriAnn DiRocco,       Marcia Madrigal,
 Garden Hotel at        1999, 8:30 a.m. to     1999, $90.00           Orange Country         Small Business
 Orange County          4:30 p.m.                                     Regulatory Affairs     Representative,
 Airport, 3350 Avenue                                                 Discussion Group       Pacific Regional
 of the Arts, Costa                                                   (OCRA), PMB 624,       Office, 510-637-
 Mesa, CA 92626, 714-                                                 5405 Alton Pkwy. 5A,   3980.
 751-5100.                                                            Irvine CA 92604-
                                                                      3718, Phone/FAX 949-
                                                                      348-9141, e-mail
                                                                      S[email protected].
Irvine: Hilton Orange  Wednesday, November    Friday, November 12,   PeriAnn DiRocco,       Marcia Madrigal,
 County Airport,        17, 1999 8:30 a.m.     1999 $90.00            Orange Country         Small Business
 18800 MacArthur        to 4:30 p.m.                                  Regulatory Affairs     Representative,
 Blvd., Irvine, CA                                                    Discussion Group       Pacific Regional
 92612, 949-833-9999                                                  (OCRA), PMB 624,       Office, 510-637-
                                                                      5405 Alton Pkwy. 5A,   3980.
                                                                      Irvine CA 92604-
                                                                      3718, Phone/FAX 949-
                                                                      348-9141, e-mail
                                                                      S[email protected].
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    The above workshops further implement the FDA Plan for Statutory 
Compliance (developed under section 406 of the FDA Modernization Act 
(21 U.S.C. 393)) by working more closely with stakeholders and ensuring 
access to needed scientific and technical expertise. They also comply 
with the Small Business Regulatory Enforcement Fairness Act (Public Law 
104-121), which requires outreach activities by Government agencies 
directed to small businesses. This notice announcing the workshops and 
a registration form may 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] TN15NO99.022



    Dated: November 5, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-29630 Filed 11-12-99; 8:45 am]
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