Areas of Expertise Compliance Regulation Policy Quality Medical Device Post Market Regulation & Studies
Industry Experience Medical Device
Writes for Medtech Insight
Latest From Steve Silverman
Opinion: Happy New Year – the Sequel
In this op/ed, consultant and former FDA official Steve Silverman looks at what he got right – and wrong – in his predictions for 2022 and walks us through his expectations for the new year.
Opinion: Digital Health Precertification -- The Little Engine That Couldn’t (Yet)
In this op/ed, former US FDA device compliance chief Steve Silverman argues that while the agency's digital health precertification (Pre-Cert) pilot program failed to make much of a splash, the concept deserves a second look -- and more Congressional support.
Opinion: FDA Isn’t A Monolith. Engage The Agency Better By Answering These 5 Questions
In this op/ed, former US FDA device compliance chief Steve Silverman argues that savvy manufacturers understand the organizational and operational differences between agency centers and offices. Here, he offers five questions firms should answer before engaging the agency.
Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?
Medtech Monthly, Ep. 1: Quality Vs. Compliance
Medtech Monthly is here! Check out the first episode of Medtech Insight's new podcast series: It's a knock-down (not really), drag-out (not really), freewheelin' (very much so) conversation about quality versus compliance, with the US FDA's Cisco Vicenty in one corner, and former FDA compliance chief Steve Silverman in the other.
Speaking Of Medtech, Ep. 9: The Case For Compliance
In this episode of Speaking Of Medtech: Over the past decade or so the US FDA and many device makers have been advocating for quality over compliance, but what if promoting compliance was seen as a good goal for the medtech industry?