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National Mammography Quality Assurance Advisory Committee

Center Date Time Location
CDRH April 28, 2003 9:00 a.m. - 6:00 p.m.

Holiday Inn
Walker/Whetstone Rooms
Two Montgomery Village Ave.
Gaithersburg, MD

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.

[Full FR Notice]

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