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| Center | Date | Time | Location |
|---|---|---|---|
| CDRH | April 28, 2003 | 9:00 a.m. - 6:00 p.m. | Holiday Inn |
Agenda:
The committee will receive information on the reauthorization of the Mammography
Quality Standards Act (MQSA) and will discuss the potential impact of reauthorization
on the current regulations particularly as it relates to personnel competency.
The committee will also discuss mechanisms to recruit and retain mammography
personnel as well as the latest draft and final MQSA compliance guidance changes.
The committee will receive updates on approved alternative standards, the status
of accreditation and certification of full field digital mammography, current
inspection follow-up actions, and an overview of inspection observations. The
MQSA compliance guidance documents, which are in a question and answer format,
are available to the public on the Internet at /cdrh/mammography.
This guidance is being updated continually in response to questions that FDA
receives from the public.
Procedure:
Interested persons may present data, information, or views, orally or in writing,
on issues pending before the committee. Written submissions may be made to the
contact person by March 31, 2003. Oral presentations from the public will be
scheduled between approximately 9:30 a.m. and 10:30 a.m on April 28, 2003. Time
allotted for each presentation may be limited. Those desiring to make formal
oral presentations should notify the contact person before March 31, 2003, and
submit a brief statement of the general nature of the evidence or arguments
they wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their presentation.
Persons attending FDA's advisory committee meetings are advised that the agency
is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Shirley Meeks, Conference Management Staff, at 301-594-1283, ext. 105, at least 7 days in advance of the meeting.
Contact Person:
Charles Finder, Center for Devices and Radiological Health (HFZ-240), Food and
Drug Administration, 1350 Piccard Dr., Rockville, MD 20850 301-594-3332 or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington,
DC area), code 12397. Please call the Information Line for up-to-date information
on this meeting.
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