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Radiological Devices Panel of the Medical Devices Advisory Committee

Agenda:
The committee will discuss, make recommendations, and vote on a premarket approval application for a computer aided detection device that identifies nodules in CT (computerized tomography) images of the lung.

Background material and meeting information will become available no later than the day before the meeting (Simply select the appropriate committee link).

Closed Committee Deliberations:
On February 3, 2004, from 8:30 a.m. to 9 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)).

Procedure:
On February 3, 2004, from 9 a.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 January 27, 2004. On February 3, 2004, oral presentations from the public will be scheduled between approximately 9:20 a.m. and 9:50 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 January 27, 2004 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 AnnMarie Williams, Conference Management Staff, at 301-594-1283, ext. 113, at least 7 days in advance of the meeting.

Contact Person:
Robert J. Doyle, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1212, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512526. Please call the Information Line for up-to-date information on this meeting.

[ Full FR Notice ]