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Re: docmts2 post# 18506

Wednesday, 06/23/2010 12:40:35 AM

Wednesday, June 23, 2010 12:40:35 AM

Post# of 59551
Docmts2, the FDA Advisory Committees HAVE ABSOLUTELY NOTHING AT ALL TO DO WITH REVIEW AND APPROVAL OF 510(k) applications. I have not read the full string above this email, but I do hope nobody was snookered by this balogna. The meetings are open to the public and they have nothing to do with application reviews. Below is the agenda from a past Radiological Devices Panel of an FDA Advisory Committee:

"The committee will hear a presentation explaining the 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, the 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 information for this meeting, including the agenda and questions for the committee, will be available to the public 1 business day before the meeting on the Internet at http://www.fda.gov/cdrh/panel (click on Upcoming CDRH Advisory Panel/Committee Meetings)."

Procedure On May 23, 2006, from 10 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.