The 'New' Alternative 510k
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 ...