FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

Radiological Devices Panel of the Medical Devices Advisory Committee

Agenda:
The committee will hear a presentation explaining FDA's Critical Path Initiative and a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design. Subsequently, FDA will present key points for the committee to consider for the reclassification of full field digital mammography (FFDM) systems from Class III to Class II devices. The committee will discuss and make recommendations on the reclassification of FFDMs.

Background material and meeting information will become available no later than one business day before the meeting (Simply scroll down to the appropriate committee heading).

Closed Committee Deliberations:
On May 23, 2006, from 9:30 a.m. to 10:00 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)) on current and pending issues regarding radiological devices.

Procedure:
On May 23, 2006, from 10:00 a.m. to 4:30 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 May 9, 2006. Oral presentations from the public will be scheduled between approximately 11:45 a.m. and 12:45 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 9, 2006. 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 contact AnnMarie Williams, Conference Management Staff, at 240-276-0450, ext. 113 at least 7 days in advance of the meeting.

Contact Person:
Nancy Wersto, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1212, ext. 144.

Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512526.