Beyond 510(k)/PMA—Safer Technologies Program

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 help explain the program. Can you tell us why there are two of them and only a day apart?Further, there is the mention of two webinars being conducted by the FDA that are relevant to this new regulatory option. You can find them via the following links. (Click the name of the webcast for information about how to view it.)Webinar—Safer Technologies Program: Draft Guidance (scheduled for November 6, 2019.)Webinar—Safety and Performance Based Pathway Performance Criteria (scheduled for November 7, 2019.)Listen to this episode and see what you think of the Safer Technologies Program. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at [email protected] so I can consider discussing them with Mike in an upcoming episode. Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify. Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.Send us Fan Mail For more medtech news and information, visit https://www.mpomag.com.