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.
What You Need to Know? 👇
What are FDA advisory committee voting procedures for medical device approvals?
FDA recommends simultaneous voting to avoid order bias, robust pre-vote discussions, clear questions without qualifiers, and public recording of all votes. These procedures ensure transparency and integrity in medical device regulatory decisions.
How do FDA advisory committees influence medical device approval decisions?
Advisory committees provide independent expert advice through discussions and formal votes on complex scientific questions. While FDA seriously considers their recommendations, the agency makes final approval decisions for medical devices.
What voting methods does FDA recommend for advisory committee meetings?
FDA recommends simultaneous voting methods including show of hands, yes/no cards, or written ballots. Sequential voting is discouraged to prevent momentum bias and ensure each member’s independent expert opinion.
When are votes typically taken during FDA advisory committee meetings?
Votes are commonly taken for product approvability decisions and scientific questions about risk/benefit profiles. They’re typically not used for clinical trial design discussions or guidance document development meetings.
How does FDA ensure transparency in advisory committee voting processes?
All votes are public with members’ names and votes read aloud and recorded. Secret ballots are inappropriate as each expert’s opinion should be clearly identified and understood by the public.
What preparation is required before FDA advisory committee voting sessions?
Members receive thorough briefing materials including voting questions in advance. Chairs must ensure robust pre-vote discussions, clarify question meanings, and confirm members feel adequately prepared before voting begins.
What You Need to Do 👇
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 đź”—
- 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 đź“‚
- 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 ID: 9c6bedc97a47fe3874878a9d02d71fcb