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U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive
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Name of CommitteeRadiological Devices Panel
Date and TimeThe meeting was held on the following dates:
Oct 16, 2002 8:30 AM - 5:00 PM
LocationHoliday Inn, Walker/Whetstone Rooms
Two Montgomery Village Ave
Gaithersburg , MD
Contact InformationRobert J. Doyle, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1212 Information can be found on the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512526. Please call the Information Line or access this Internet page for up-to-date information on this meeting. (E-mail contact RXD@CDRH.FDA.GOV)
Agenda

This meeting is being rescheduled from October 16th, by mutual agreement between FDA and the sponsor, for administrative and logistical reasons.

The committee will discuss, make recommendations, and vote on a premarket approval application for a device that produces a computerized thermal image of the breast of women recommended for biopsy. Background information, including the agenda and questions for the committee, will be available to the public one business day before the meeting, on the Internet at http://www.fda.gov/cdrh/panelmtg.html. Material for the October 16, 2002 meeting will be posted on October 15, 2002.

ProcedureOn October 16, 2002, from 8:30 a.m. to 1 p.m., and from 1:30 p.m. to 5 p.m., the meeting is open to the public. 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 October 7, 2002. On October 16, 2002, oral presentations from the public will be scheduled between approximately 9:15 a.m. and 9:45 a.m., and for an additional 30 minutes near the end of the committee deliberations. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before October 9, 2002, 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.

Closed Committee InformationOn October 16, 2002, from 1 p.m. to 1:30 p.m., the meeting will be closed to the public to permit FDA to present to the committee trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)) regarding pending and future agency issues.
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.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
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