Heads turn and crowds make way for VIPs as they make their way down the red carpet. What if your medical device could receive this same treatment? The FDA Breakthrough Device Designation program is a way to roll out the red carpet for a device to follow to achieve commercialization. This discussion will provide insights to help you understand the FDA Breakthrough Device Designation program and determine whether this designation should be considered as part of your device development program. DuVal & Associates will share experiences and best practices to help you successfully navigate the Breakthrough Device Designation process to accelerate commercialization of your product that is worthy of VIP status.
In this program, we will cover the following topics:
- Foundations and history of the Breakthrough Device Designation program
- Breakthrough Device Designation Criteria
- How to complete a Breakthrough Device Designation request
- Maximizing benefits of a Breakthrough Device Designation
Featured Speakers:
Lisa Pritchard
BSEEE, DuVal & Associates