CDRH advisory committees provide independent, professional advice from outside experts on the development, safety and effectiveness, and regulation of medical devices. Going before an advisory committee can be a make-or-break moment for a device sponsor. Industry representatives (IRs) to these meetings play a critical role, helping to assure that these meetings focus on device safety and effectiveness and the issues under discussion. In response, AdvaMed has updated its training document for IRs.?Key learnings include:?
- Authorization, makeup, and conflict-of-interest review
- What happens at advisory committee meetings and which topics are on and off the table
- The IR’s role and best practices before and during committee meetings
- How consumer and patient representatives participate in committee meetings