Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a recently announced alternative 510(k) pathway that attempts to trim the time to clearance for medical device manufacturers. Is it, however, an option that already exists packaged in a new wrapper or is it a truly new option put forth by Gottlieb's FDA? Listen to this episode and then see what you think. Specifically, the following questions and topics are addressed in this discussion: What is the “new” alternative 510(k)?What are the types of 510ks and how do they differ?What does “least burdensome” mean?Does abbreviated 510k mean less time or less work for the company?How does this compare to what’s available in the EU?Which is a better system between the new MDR and this 510k?What are the lessons to be learned/advice moving forward?For Further Reference Check out the following links for more information about this topic.New Steps to Facilitate Beneficial Medical Device Innovation The