1.     Understand the history of the issue and how it was raised to the level of FDA interest.

2.     Learn the goals of the advisory committee and the questions they will be asked to vote upon. Advisory Committees members provide advice to the FDA, based on 4-5 questions the FDA asks the committee members to vote on. Sample questions include:

·      Is there reasonable assurance that X device is safe for indications(s) A (and B, etc.)?

·      Is there reasonable assurance that X device is effective for indications(s) A (and B, etc.)?

·      Do the benefits of X device for indication(s) A (and B, etc.) outweigh the risks of device X for indication(s) A (and B, etc.)?

3.     Get to know the members of advisory committee to understand their positions and be able to address them specifically on issues that are important to them.
The Medical Devices Advisory Committee, Circulatory System Devices Panel

4.     Familiarize yourself with the process, the cadence of the hearing, the room itself.

SAMPLE AGENDA

·             Introduction

·             Conflict of interest

·             Presentation by sponsor, 30-60 min

·             Presentation by FDA

·             Open Public Hearing, 30-60 min

·             FDAs questions for the committee; Committee discussion and deliberation;

·             Vote and discussion

There are laws that govern how ACs are set up -- Federal Advisory Committee Act. There are also FDA regulations and guidance’s that talk about public engagement and votes the committee can take.  You can get an idea of some questions they may ask from the four items noted in the FDA Notice.  See FDA.gov.

1 Comment