Voting Procedures for Advisory Committee Meetings
This guidance outlines uniform procedures for voting during FDA advisory committee meetings. It provides recommendations for FDA advisory committee members and FDA staff on how to conduct voting processes effectively while ensuring transparency and integrity of the results.
Recommended Actions
- Establish a standardized simultaneous voting procedure for advisory committee meetings
- Develop clear templates for presenting voting questions without leading language
- Create a process for documenting and publishing voting results
- Implement a system for providing comprehensive briefing materials in advance
- Set up procedures for pre-vote discussions and post-vote explanations
- Create guidelines for chairs regarding the introduction of new voting questions
- Establish a protocol for managing the timing and flow of voting procedures
- Develop a process for recording and maintaining transparency of voting records
- Create training materials for advisory committee members on voting procedures
- Establish a verification process to ensure voting questions are clear and well-understood before voting begins
Key Considerations
Other considerations
- Voting should be conducted simultaneously rather than sequentially to avoid order bias
- Questions for voting should be clear, minimal qualifiers, and avoid double/triple negatives
- No discussion should occur during the voting process
- Names of committee members and their votes should be made public
- Robust discussion should occur before voting
- Briefing materials should be provided in advance and include potential voting questions
- Committee chairs must consult with FDA officials before introducing new voting questions
- Non-voting members should be encouraged to participate in discussions
- Members should have opportunity to explain their votes after voting
Relevant Guidances
- Procedures for Medical Devices Advisory Committee Panel Meetings
- Public Disclosure of Advisory Committee Members’ Financial Interests and Waivers
- Public Participation in Open Public Hearing Sessions of Advisory Committee Meetings
- 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
Original guidance
- Voting Procedures for Advisory Committee Meetings
- HTML / PDF
- Issue date: 2008-08-01
- 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: 9c6bedc97a47fe3874878a9d02d71fcb
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