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General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee

Agenda:
On August 25, 2005, the committee will hear a presentation on the FDA 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.

On August 25 and 26, 2005, the committee will discuss and make recommendations on the classification of five preamendments medical devices: Bone wax, medical maggots, medicinal leeches, tissue expander, and wound dressing with a drug.

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

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 August 11, 2005. On August 25, 2005, oral presentations from the public will be scheduled between approximately 10:15 a.m. and 10:45 a.m., 1:45 p.m. and 2:15 p.m., and 4:30 p.m. and 5 p.m. On August 26, 2005, oral presentations from the public will be scheduled between approximately 9:30 a.m. and 10 a.m., 1 p.m. and 1:30 p.m., and 3:45 p.m. and 4:15 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before August 11, 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, Conference Management Staff, at 240-276-0450, ext. 113, at least 7 days in advance of the meeting.

Contact Person:
David Krause, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 141.

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 3014512519.