Speaking Of Medtech, Ep. 2 – Breakthrough Medical Devices
Executive Summary
On this episode of our new podcast series Speaking Of Medtech, former US FDA device center compliance chief Steve Silverman and Medtech Insight executive editor Shawn M. Schmitt talk about the agency’s Breakthrough Devices Program – what it is, how it operates, how device makers can take full advantage of the pathway, and more.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
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A ‘STeP’ Backward? Expert Predicts ‘Slow, Quiet Death’ For FDA’s STeP Novel Devices Program
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‘STeP’ By ‘STeP’: FDA Finalizes Accelerated Pathway For Novel Devices, Combo Products