[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:
BILLING CODE 4160-01-F
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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]
BILLING CODE 4160-01-C