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Steve Silverman

Steve Silverman is the president of The Silverman Group, a consultancy that serves medical device companies on regulatory, strategy and policy issues. Before this, Steve worked as VP of Technology and Regulatory Affairs with AdvaMed, the leading medical device trade association. Steve focused there on device quality and compliance, premarket approval, advertising and promotion, and combination products. Steve brings to these roles international consulting experience and US Food and Drug Administration leadership positions. At the FDA, Steve directed the Office of Compliance within the agency’s Center for Devices and Radiological Health (CDRH), where he led device quality initiatives, engaged Congress and the press, and guided the office’s reorganization. Steve’s FDA experience includes positions as assistant director, the Office of Compliance within the FDA’s Center for Drug Evaluation and Research (CDER), and associate chief counsel. Adding to these are past positions with the US Department of Justice and the Federal Trade Commission.

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.

FDA Regulation

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.

Regulation FDA

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.

Medical Device FDA

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?

Speaking of Medtech FDA

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.

Medtech Monthly Quality

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?

Speaking of Medtech Compliance
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