22 février, 2005 05:42
The dates for the FDA hearings have finally been released. . .Here they are.
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
April 11, 2005 8 a.m. - 5:30 p.m.
April 12, 2005 8 a.m. - 6 p.m.
April 13, 2005 8 a.m. - 6 p.m.
Hilton Washington DC North
Grand Ballroom
620 Perry Pkwy.
Gaithersburg, MD
Agenda:
On April 11, 2005, the committee will hear oral presentations from the public.
On April 12 and 13, 2005, the committee will discuss, make recommendations, and vote on two premarket approval applications for Silicone Gel-Filled Breast Prostheses.
Background material and meeting information will become available no later than one business day before each meeting day (Simply select 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 March 28, 2005. Oral presentations from the public will be scheduled on April 11, 2005, between approximately 8 a.m. and 5:30 p.m., and on April 12 and 13, 2005, between approximately 2:45 p.m. and 3:45 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 28, 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 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, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512519. Please call the Information Line for up-to-date information on this meeting.
