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

Zusammenfassung

The Food and Drug Administration (FDA or Agency) is announcing the availability of the 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 Medical Devices Dispute Resolution Panel (DRP). This guidance describes the general circumstances in which CDRH consults with a panel, the process for exchange of information among 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.