Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the still relatively new Breakthrough Devices Program (click to review the guidance). Since it was only introduced last year, there are still a number of questions device manufacturers have about the program. With this in mind, we thought it would be a great topic to cover as part of this “Beyond 510(k)/PMA” series. Specifically, we address a number of questions, including:What is the purpose of the Breakthrough Devices Program and why does it exist?Is the BDP a “pathway” to market like the 510k or PMA?How early in the product development lifecycle should we consider a BDP?What are the requirements of the Breakthrough Devices Program?What are the mechanics of the process?What goes into the BDP Pre-Sub Package?What is the benefit of BDP status?What if you don’t like FDA’s decision, can I appeal?Is there a database of BDP devices?Should we issue a press release announcing our BDP designation?Wh