Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the brand new (in fact, yet-to-be-launched) Safer Technologies Program (click to review the guidance). Since it was only recently introduced, 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 safer technologies program?How does this program differ from the Breakthrough Designation Program?So like BDP, STeP is not a regulatory pathway on its own, correct?What are the criteria for eligibility into STeP?What are the mechanics of STeP?Is STeP an already active program?Are the BDP and now STeP part of an effort by the FDA to encourage true innovative technologies and perhaps disrupt the history of incremental innovation within the industry?I know the FDA is hosting a pair of webinars to he