General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.
Date and Time:The meeting will be held on January 31, 2000, 9 a.m. to 6 p.m.
Location:Gaithersburg Holiday Inn, Walker/Whetstone Rooms, Two Montgomery Village Avenue, Gaithersburg, MD.
Contact Person:Charles Finder, Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration, 1350 Piccard Drive, 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.
Agenda: The committee will discuss the establishment of a proposed demonstration project to assess the efficacy of less than annual inspections as described in the Mammography Quality Standards Reauthorization Act of 1998 and will continue the discussion of MQSA compliance guidance. The committee will also receive updates on the status of facility non-compliance under final regulation inspections, accreditation and certification of full field digital mammography, States as Certification Agencies under MQSA, and Voluntary Stereotactic Accreditation Programs. The MQSA compliance guidance documents, which are in a question and answer format, are available to the public on the Internet using the World Wide Web (WWW) http://www.fda.gov/cdrh/mammography). This guidance is being updated continually in response to questions that FDA receives from the public. Additional information regarding guidance updates may be obtained by calling the Information Line.
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 January 10, 2000. Oral presentations from the public will be scheduled between approximately 9:30 a.m. and 10:30 a.m. on January 31, 2000. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before January 10, 2000, 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.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Date and Time:The meeting will be held on January 31, 2000, 9 a.m. to 6 p.m.
Location:Gaithersburg Holiday Inn, Walker/Whetstone Rooms, Two Montgomery Village Avenue, Gaithersburg, MD.
Contact Person:Charles Finder, Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration, 1350 Piccard Drive, 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.
Agenda: The committee will discuss the establishment of a proposed demonstration project to assess the efficacy of less than annual inspections as described in the Mammography Quality Standards Reauthorization Act of 1998 and will continue the discussion of MQSA compliance guidance. The committee will also receive updates on the status of facility non-compliance under final regulation inspections, accreditation and certification of full field digital mammography, States as Certification Agencies under MQSA, and Voluntary Stereotactic Accreditation Programs. The MQSA compliance guidance documents, which are in a question and answer format, are available to the public on the Internet using the World Wide Web (WWW) http://www.fda.gov/cdrh/mammography). This guidance is being updated continually in response to questions that FDA receives from the public. Additional information regarding guidance updates may be obtained by calling the Information Line.
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 January 10, 2000. Oral presentations from the public will be scheduled between approximately 9:30 a.m. and 10:30 a.m. on January 31, 2000. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before January 10, 2000, 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.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
