Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the third most commonly used (although still substantially less than the 510(k) and PMA) regulatory pathway available to medical device manufacturers. Since it is not nearly as common as the two primarily used pathways, the De Novo is not nearly as understood as them. In order to shed light on when this option could be most beneficial or be the best option for a regulatory submission, we attempt to provide an overview of it—a De Novo 101, if you will. Specifically, we address a number of questions, including:What is the De Novo regulatory pathway?How does the De Novo differ from the PMA and 510(k) regulatory pathways?For what situation or type of device is the best case to use the De Novo pathway?When shouldn’t the De Novo be used?Do you have any suggestions or best practices for using a pre-sub meeting when planning to use the De Novo pathway?Listen to this episode and see what you think of