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

Issue Date: September 1, 2017
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Advisory Committees, 510(k), Premarket Approval (PMA), HUD/HDE, Administrative / Procedural, Labeling, Safety – Issues, Errors, and Problems, Anesthesiology , Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Physical Medicine, Orthopedic, Ophthalmic, Obstetrical & Gynecological, Neurological, Molecular and Clinical Genetics, Immunology & Microbiology , Cardiovascular , Hematology & Pathology , General Hospital & Personal Use , General & Plastic Surgery , Gastroenterology-Urology , Ear, Nose & Throat , Dental , Clinical Chemistry & Clinical Toxicology , Radiology, Laser Notice
Status: Final

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

The Center for Devices and Radiological Health (CDRH) is issuing this guidance to provide information regarding the processes for meetings of the Medical Devices Advisory Committee panels other than the Medical Devices Dispute Resolution Panel (DRP). The term “panel,” as used in this guidance, refers to the panels described in the Medical Devices Advisory Committee charter, excluding the 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.

Download the Guidance Document