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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.

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By ReguVirta
3 min read

What You Need to Know? 👇

What is the purpose of FDA Advisory Committee Open Public Hearings for medical device professionals?

Open Public Hearings (OPH) allow medical device professionals to present relevant information and views to FDA advisory committees. These sessions provide independent expert advice on scientific, technical, and policy matters related to FDA-regulated products, enhancing FDA’s decision-making process.

How do I request to speak at an FDA Advisory Committee meeting about a medical device?

Submit your request to the FDA contact person listed in the Federal Register notice by the deadline. Include your name/organization, contact information, presentation description, and requested time. FDA recommends submitting via mail, telephone, fax, or email.

What financial disclosures are required when speaking at FDA Advisory Committee meetings?

While not mandatory for speakers, FDA encourages disclosure of financial relationships with meeting topics and parties. This includes company payments for travel, grants, consulting fees, or any financial interests with sponsors or competitors of discussed products.

How much time is typically allocated for presentations at FDA Advisory Committee Open Public Hearings?

FDA usually allots 5-10 minutes per speaker, depending on the number of requests. If many people request to speak, FDA may reduce individual time allocations or extend the OPH session to accommodate more speakers.

Can I use audio-visual equipment during my FDA Advisory Committee presentation?

Yes, audio-visual equipment is available at meetings. Submit a written request for equipment use along with an electronic version of your presentation at least one week before the meeting. Consult with the FDA Designated Federal Officer regarding software/hardware compatibility.

What happens if I cannot attend the FDA Advisory Committee meeting after confirming my participation?

Contact FDA representatives immediately. Depending on time and resources, alternatives may include rescheduling your presentation, having a representative speak on your behalf with written authorization, or including your statement in the public record via the docket.

What You Need to Do 👇

  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 🔗

Related references and norms 📂

  • 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 ID: b69af454f1b200a555984280d93e5d32
FDA guidance, Final
Radiation-Emitting Products Tobacco Medical Devices Food & Beverages Dietary Supplements Drugs Animal & Veterinary Food & Color Additives Biologics Cosmetics Advisory Committees
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