Advisory Panel Review
FDA's use of formal advisory panels for Class III PMA review is a distinctive feature of the US system. Panel meetings are public, and panel recommendations are publicly available.
What are advisory panels?
FDA has 18 Medical Device Advisory Committees, each comprising independent experts in a specific medical specialty. For complex or high-risk PMA applications, FDA may convene a panel to provide independent expert advice.
When is panel review used?
Panel review is not required for all PMAs — FDA has discretion. Panels are typically convened when:
- The device presents novel or complex safety/effectiveness questions
- The clinical data is complex or controversial
- The benefit-risk determination is not straightforward
- FDA wants independent expert input on proposed labelling or post-approval conditions
The panel meeting process
Panel deliberates and votes on the following questions: Is the device safe for its intended use? Is the device effective for its intended use? Do the benefits outweigh the risks? Are there recommended conditions or labelling modifications?
Panel recommendations are advisory, not binding
FDA is not bound by the panel's recommendation, though it typically follows it. FDA must explain in writing if it diverges from a panel recommendation.