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CDRH Advisory Meeting Materials Archive

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Name of CommitteeNational Mammography Quality Assurance Advisory Committee
Date and TimeThe meeting was held on the following dates:
Apr 28, 03 9:00 AM - 6:00 PM
LocationHoliday Inn, Walker/Whetstone Rooms
Two Montgomery Village Ave.
Gaithersburg , MD
Contact InformationCharles 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.
AgendaThe 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 http://www.fda.gov/cdrh/mammography. This guidance is being updated continually in response to questions that FDA receives from the public.
ProcedureInterested 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.
ConductFDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ for procedures on public conduct during advisory committee meetings.
Related Documents
Briefing: Text
Transcript: Text
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
 
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