Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we highlight a number of areas in which the agency’s regulatory oversight could be considered lacking. If the agency incorporated the highlighted ideas from this podcast, might it smooth the pathway to market for some products? Might it enhance communication with the FDA? Could they be welcome additions? Specifically, the following questions are addressed:Can you please take a minute to explain why we are dedicating an episode to what’s missing from regulatory and quality systems?First topic on the list is communicating with the FDA. Do we need a Wellness Device registration, wellness pre-sub, or wellness device database?What about a catch-up 510k and letter to file pre-sub?How about a pre-sub for manufacturing issues or to resolve 483s and/or warning letters?Let’s jump to regulatory pathway. Is a pathway needed that provides a de novo like version of the PMA?Staying in this realm, what about the idea o