Monday, June 4; 4 PM – 5 PM
Presenters: Chris Mullin, Director of Product Development Strategy (NAMSA)
Richard Kotz, Principal Product Development Strategist (NAMSA and formerly with the FDA)
Often, U.S. Food & Drug Administration (FDA) Advisory Panel meetings are the capstone to what is characteristically a long and arduous medical device development journey. While these meetings typically close with a voting session on a device’s approvability, recent real-world experiences demonstrate that achieving a favorable set of panel votes does not always guarantee swift FDA approval of the device under consideration.
This session will seek to provide global medical device manufacturers a better understanding of how to effectively prepare and plan for successful Advisory Panel meetings, and will include information on: