Device Advisory Committee Meeting Guidance Out

FDA has issued a finalized guidance, Procedures for Meetings of the Medical Devices Advisory Committee, with information on the processes for meetings of the various Medical Devices Advisory Committee panels, other than the dispute resolutions panel. A draft of the guidance was issued 4/1/15. It supersedes a 7/22/2000 guidance and a 5/3/1991 blue book memo.

The guidance describes the general circumstances in which CDRH consults with a panel, the process for exchange of information between CDRH, the members of the panel, industry, and the public, and the conduct of panel meetings.

The Medical Devices Advisory Committee includes 17 panels in addition to the dispute resolution panel. According to their specialty area and authorization, the panels advise the commissioner in discharging responsibilities as they relate to assuring medical device safety and efficacy or, as required, for any other product for which the agency has regulatory responsibility.