Options with an Overly Burdensome FDA
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the options available to a medical device firm who thinks the FDA is requiring them to take unfair measures or is being overly burdensome. We discuss the formal and informal options as well as the potential consequences. Specifically, the following questions are addressed: If after a 510k submission or pre-sub meeting, is there something you can do if you feel the FDA is be...