FDA's Breakthrough Designation Program: Better Practices for Getting to Market Sooner

Tue. February 5| 10:15 AM - 11:00 AM | 210D

Show: MD&M West 2019

Track: MD&M West: Regulatory & Quality Update

Badge Type: Paid

The breakthrough designation program (BDP), created as part of the 21st Century Cures Act in 2016, represents the next in a series of "special programs" to encourage device companies to pursue "breakthrough technologies," often in areas of unmet clinical need. FDA issued a guidance on the BDP in 2017, with the goal being to help patients gain timely access to breakthrough technologies that have the potential to change lives without compromising safety or effectiveness. That's the goal, but is that reality?

Topics covered include:
  • How does a manufacturer apply for BDP designation?
  • Why are nearly half of BDP applications rejected?
  • What should be done to avoid rejection/delay
  • Case examples demonstrating time and cost savings

Speakers

Mike Drues, PhD

Mike Drues, PhD

President

Vascular Sciences

Role: Speaker