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Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee

Agenda:
The committee will hear 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. The committee will also discuss, make recommendations, and vote on a premarket approval application for a spectroscopy-based cervical imaging system intended for use as an adjunct to colposcopy to enhance the identification and selection of biopsy sites.

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

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 May 10, 2005. Oral presentations from the public will be scheduled between approximately 9 a.m. and 9:30 a.m. and between approximately 3:30 p.m. and 4 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 10, 2005, 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, at 240-276-0450, ext. 113, at least 7 days in advance of the meeting.

Contact Person:
Michael Bailey, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1180, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512524. Please call the Information Line for up-to-date information on this meeting.