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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: The Case For Quality – AND Compliance

The medtech industry should promote regulatory compliance as a good goal, former US FDA device center compliance chief Steve Silverman argues in this opinion piece.

Compliance Quality

Speaking Of Medtech, Ep. 8: Medical Device Quality

In this episode of Speaking Of Medtech: Too often quality is overshadowed by regulatory and compliance, and some manufacturers view quality as an obstacle to getting product into the marketplace rather than a concept that will help a company save money, reputation, and patient lives.

Speaking of Medtech Quality

Speaking Of Medtech, Ep. 7: Real-World Evidence And Data

In this episode of Speaking Of Medtech we’re talking real-world evidence and real-world data – what it is, who’s using it, and why the medtech industry and the US FDA are so keen to collect it.

Speaking of Medtech Real-World Evidence

Speaking Of Medtech, Ep. 6: 2022 Predictions For FDA’s Device Center

In this episode of Speaking Of Medtech we’re breaking out the crystal ball to give a few predictions of what could be in store this year for industry and the US FDA’s Center for Devices and Radiological Health. From the ongoing COVID-19 pandemic to digital devices and facility inspections, there’s a lot of ground to cover.

Speaking of Medtech FDA

Happy New Year! (I Think?): Some 2022 Predictions For FDA’s Device Center

Former US FDA device center compliance chief Steve Silverman considers what industry can expect this year, from continued pandemic activities to enhanced facility inspections – and more.

FDA Coronavirus COVID-19

Speaking Of Medtech, Ep. 5: MDUFA V User-Fee Negotiations

In this episode of Speaking Of Medtech we discuss the Medical Device User Fee Amendments, or MDUFA, the negotiations for which come around every five years. The MDUFA V talks between industry and the US FDA appear with the inevitability of an unloved season – it seems no one is ever terribly excited to engage in the user-fee process. Here, we break things down.

Speaking of Medtech User Fees
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