De Novo Final Rule

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the final rule recently announced for the FDA’s de novo regulatory pathway. As part of the discussion, the de novo is explained, when it should be used, why it exists, and what points of interest were included in the final rule. Specifically, the following questions are addressed:Can you please briefly explain what the de novo regulatory pathway is?How does this option differ...