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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

Come On In, The Water’s Fine: FDA Should Fully Embrace Remote Inspections

Former US FDA device center compliance chief Steve Silverman argues in this opinion piece that the agency and stakeholders should take steps now to develop a remote-inspection framework for medical device manufacturers.

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