Procedures for Device Advisory Committee Meetings: FDA Finalizes Guidance
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday finalized guidance from 2015 on advisory committee meetings.
Background
Other than the Medical Devices Dispute Resolution Panel (which this guidance does not address), there are 17 device panels: (1) Anesthesiology and Respiratory Therapy Devices; (2) Circulatory System Devices; (3) Clinical Chemistry and Clinical Toxicology Devices; (4) Dental Products; (5) Ear, Nose and Throat Devices; 6) Gastroenterology and Urology Devices; (7) General and Plastic Surgery Devices; (8) General Hospital and Personal Use Devices; (9) Hematology and Pathology Devices; (10) Immunology Devices; (11) Microbiology Devices; (12) Molecular and Clinical Genetics; (13) Neurological Devices; (14) Obstetrics and Gynecology Devices; (15) Ophthalmic Devices; (16) Orthopaedic and Rehabilitation Devices; and (17) Radiological Devices.
Details
The guidance explains what FDA may refer a matter to a panel for, including advice on a premarket submission and regulatory issues (such as classification/reclassification). It also explains a panel’s expertise and preparation for a meeting.
In addition, the guidance explains how meetings are conducted, with a breakdown of the presentation order, deliberations, questions and voting.
In terms of differences from the draft, FDA says it "revised the guidance as appropriate in response to the comments,” and that it replaces “Guidance on Amended Procedures for Advisory Panel Meetings” and the guidance document entitled “Panel Review of Premarket Approval Applications #P91-2 blue book memo."