Procedures for Medical Devices Advisory Committee Panel Meetings

Recommended Actions

1. Determine if panel review is needed based on novel technology, uncertain benefits/risks, or data quality issues
2. Plan timeline working backwards from meeting date:
   • Submit briefing materials 42 or 22 business days before meeting
   • Exchange presentation slides 5 business days before meeting
   • No new data after 22 business days before meeting
3. Prepare comprehensive briefing materials including:
   • Executive summary
   • Relevant submission sections
   • Proposed labeling
   • Study protocols
   • Key publications
4. Prepare presentation limited to 60-90 minutes focusing on key points
5. Be prepared to:
   • Answer panel questions during deliberations
   • Provide clarifications as needed
   • Present final viewpoint summary before voting
   • Discuss potential labeling changes or other controls that could affect benefit-risk
6. After meeting:
   • Review complete panel proceedings
   • Work interactively with FDA on next steps
   • Consider panel recommendations for submission modifications

Key Considerations

Labelling

• Proposed labeling should be included in briefing materials for premarket submission meetings
• Changes to labeling may be discussed during panel deliberations to alter benefit-risk assessment

Safety

• For PMA applications, panel members vote on reasonable assurance of safety
• For HDE applications, panel members vote on unreasonable risk of illness or injury

Other considerations

• Panel must include adequate expertise (at least 2 voting members with relevant clinical expertise and 1 with device technology expertise)
• Briefing materials must be submitted 42 business days before meeting if containing confidential information, or 22 business days if fully releasable
• Industry presentations generally limited to 60-90 minutes
• Open public hearing minimum of 60 minutes required
• Formal voting procedures required for premarket submission meetings
• Panel members must explain their votes and any conditions that could change their vote
• Post-meeting summary posted within 2 business days and full transcript within 60 days

  Relevant Guidances

• Voting Procedures for Advisory Committee Meetings
• Public Participation in Open Public Hearing Sessions of Advisory Committee Meetings
• Public Disclosure of Advisory Committee Members’ Financial Interests and Waivers
• Evaluating Appearance Issues and Granting Participation Authorizations for Advisory Committee Members (Draft)

Related references and norms

• 21 CFR Part 14: Public Hearing Before a Public Advisory Committee
• 21 CFR Part 860: Medical Device Classification Procedures
• 21 CFR Part 814: Premarket Approval of Medical Devices

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Original guidance

• Procedures for Medical Devices Advisory Committee Panel Meetings
• HTML / PDF
• Issue date: 2017-09-01
• Last changed date: 2019-03-12
• Status: FINAL
• Official FDA topics: Physical Medicine, Errors, Laboratory Tests, Dental, IVDs (In Vitro Diagnostic Devices), Clinical Chemistry & Clinical Toxicology, HUD/HDE, Orthopedic, Nose & Throat, Hematology & Pathology, Gastroenterology-Urology, 510(k), Premarket, Ear, Immunology & Microbiology, Radiology, Safety - Issues, Ophthalmic, Laser Notice, Medical Devices, Obstetrical & Gynecological, Cardiovascular, Labeling, General Hospital & Personal Use, Molecular and Clinical Genetics, General & Plastic Surgery, and Problems, Premarket Approval (PMA), Anesthesiology, Advisory Committees, Administrative / Procedural, Neurological
• ReguVirta summary file ID: eeb2856ef8755ba3c058f6d24b1e1e13