Procedures for Meetings of the Medical Devices Advisory Committee; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Procedures for Meetings of the Medical Devices Advisory Committee." The Center for Devices and Radiological Health (CDRH) is issuing this guidance to provide additional information regarding the processes for meetings of the Medical Devices Advisory Committee panels other than the Dispute Resolution Panel (DRP). This 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. This guidance supplements existing FDA Agency-wide guidance on the conduct of Advisory Committee meetings. This draft guidance is not final nor is it in effect at this time.