CDRH Releases Draft Guidance for Medical Device Advisory Committee Meetings
March 31, 2015—The US Food and Drug Administration (FDA) announced that the Center for Devices and Radiological Health (CDRH) released a draft guidance, “Procedures for Meetings of the Medical Devices Advisory Committee,” for industry and FDA staff. The draft guidance provides additional information regarding the processes for meetings of Medical Devices Advisory Committee panels other than the Medical Devices Dispute Resolution Panel. The document is available on the FDA website.
The FDA noted that 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. This draft guidance describes the general circumstances in which the CDRH convenes and consults with a panel of the Medical Devices Advisory Committee; the process and timeline for exchange of information between CDRH and the members of the panel, industry, and the public; and the conduct of panel meetings.
As noted by the CDRH in the document, the guidance supplements existing FDA agencywide guidance on the conduct of advisory committee meetings. When final, this document will supersede Guidance on Amended Procedures for Advisory Panel Meetings, issued July 22, 2000, and Panel Review of Premarket Approval Applications #P91-2, issued May 3, 1991.
The guidance applies only to panels of the Medical Devices Advisory Committee other than the Dispute Resolution Panel. It does not apply to other device-related or radiation-emitting product advisory committees, such as the Device Good Manufacturing Practice Advisory Committee, the National Mammography Quality Assurance Advisory Committee, or the Technical Electronic Product Radiation Safety Standards Committee.