Latest From Steve Silverman
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.
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.
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.
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.
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.
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.