Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss two recently issued FDA guidance documents. As they can be coupled together, we discussed both in one podcast. They are:Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions (August, 2019) (Click here to read the guidance.)Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (August, 2019) (Click here to read the guidance.)Specifically, we address a number of questions, including:Can you please provide a brief overview of what's in these guidances and what their purpose is? Why is PMA, HDE and de novo included but 510k is NOT included in this guidance?When is higher risk acceptable and what is the tie-in to the term uncertainty?What else is important in these guidances and what are the most important takeaw