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Welcome to the Advanced Manufacturing West 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

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

Mike Drues, PhD (President, Vascular Sciences)

Location: 210D

Date: Tuesday, February 5

Time: 10:15am - 11:00am

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

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

Presentation File