CDRH Industry: FDA Releases Final Guidance on Procedures for Meetings of the Medical Devices Advisory Committee

Today, the FDA released the final guidance document "Procedures for Meetings of the Medical Devices Advisory Committee." This final guidance clarifies the procedures, processes and participant roles for advisory committee meetings.

The final guidance includes:

• general information about the topics and types of panel meetings, including premarket submission and regulatory issues meetings;
• more information about the process for premarket submission panel meetings, including briefing materials, timing, updates to communication procedures, and when a panel by teleconference may be appropriate;
• clarification on the conduct of panel meetings, including industry and Center for Devices and Radiological Health (CDRH) presentations, and voting procedures;
• information about post meeting activities, such as posting a summary of the meeting; and
• updates that reflect statutory changes from the 21st Century Cures Act.

If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health