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Advisory Panel Review

US-unique

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​

  1. FDA posts a public notice of the panel meeting (typically 60+ days in advance)
  2. The applicant presents its data to the panel (typically 1–2 hours)
  3. FDA presents its own analysis and questions
  4. Public comment session
  5. Panel deliberates and votes on:
    • Whether the device is safe
    • Whether the device is effective
    • Whether the benefits outweigh the risks
    • Any conditions or labelling recommendations

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.

Official resources​