Post

Public Participation in Open Public Hearing Sessions of Advisory Committee Meetings

This guidance outlines procedures and requirements for public participation in the Open Public Hearing (OPH) sessions of FDA Advisory Committee meetings. It specifically addresses how members of the public, industry representatives, consumer advocacy groups, and professional organizations can participate and present their views during these sessions.

  1. Monitor Federal Register for relevant FDA Advisory Committee meetings
  2. Submit speaker request before the deadline including all required information
  3. Prepare and submit written materials by the specified deadline
  4. Prepare financial disclosure statement if applicable
  5. Submit any audio-visual requirements one week before the meeting
  6. Prepare presentation to fit within allocated time (typically 5-10 minutes)
  7. Arrive early for check-in on meeting day
  8. Follow meeting protocol and time limitations during presentation
  9. Be prepared for potential questions from committee members

Key Considerations

Other considerations

  • A minimum of 60 minutes must be dedicated to OPH sessions for oral presentations
  • Speakers must submit requests to speak before the meeting deadline
  • Request should include:
    • Name of individual or group
    • Contact information
    • Description of presentation
    • Time requested (typically 5-10 minutes per speaker)
  • Financial disclosure is encouraged for speakers regarding relationships with the topic or parties involved
  • Written materials should be submitted by the deadline specified in the Federal Register notice
  • Audio-visual equipment requests must be submitted at least one week in advance
  • Speakers must check in at registration and follow allocated time limits
  • All presentations are recorded and included in meeting transcripts

    Relevant Guidances

  • Public Disclosure of Advisory Committee Members’ Financial Interests and Waivers
  • Procedures for Medical Devices Advisory Committee Panel Meetings
  • 21 CFR Part 14: Public Hearing Before a Public Advisory Committee

Original guidance

  • Public Participation in Open Public Hearing Sessions of Advisory Committee Meetings
  • HTML / PDF
  • Issue date: 2013-05-15
  • Last changed date: 2019-04-20
  • Status: FINAL
  • Official FDA topics: Radiation-Emitting Products, Tobacco, Medical Devices, Food & Beverages, Dietary Supplements, Drugs, Animal & Veterinary, Food & Color Additives, Biologics, Cosmetics, Advisory Committees
  • ReguVirta summary file ID: b69af454f1b200a555984280d93e5d32
This post is licensed under CC BY 4.0 by the author.