In Vivo is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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: At Least It’s Not Fruitcake – My Annual FDA Predictions

Consultant (and former FDAer) Steve Silverman is back with a reflection on his predictions for 2023, and well as what he expects to see in the coming year. 

Regulation Compliance

Opinion: Smart Device Firms (and Investors) Unwind Regulatory Risk

Investments in medtech firms have been drying up, with some speculating the reason lies in the degree of regulatory uncertainty inherent to the field. In this opinion piece, consultant and former FDAer Steve Silverman describes how device companies can help investors clarify the risk. 

Regulation Financing

Opinion: Getting Work Done in the ’New Normal‘ CDRH

In this op/ed, consultant and former FDA official Steve Silverman reveals how medical device firms can best interact with the US Food and Drug Administration's Center for Devices and Radiological Health as the COVID-19 pandemic recedes.

FDA Policy

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
See All