New FDA Guidance for Medical Device Advisory Committees

Today, the U.S. Food and Drug Administration released a draft guidance: “Procedures for Meetings of the Medical Devices Advisory Committee.”  

Advisory committees play an important role in the FDA’s regulation of medical devices by providing independent expert advice on complex scientific and technical matters.

The new draft guidance describes the general circumstances in which FDA’s Center for Devices and Radiological Health (CDRH) convenes a panel of the Medical Devices Advisory Committee. The guidance also discusses the process and timelines for the exchange of information between CDRH and the members of the panel, industry, and the public. 

Center for Devices and Radiological Health
Food and Drug Administration