Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use of an FDA pre-sub (or pre-submission) prior to making a formal submission of a 510(k) or PMA to the agency. While a number of companies are taking advantage of this, as of right now, still free opportunity, many others are not. When submissions are being rejected at such high percentages (Mike offers the numbers in this podcast), it only makes sense for more companies to utilize this opportunity. Specifically, the following questions are addressed in this discussion:  What is a “pre-sub” and why should engineers need to care about it?How early in the product development lifecycle should companies involve FDA?What is a pre-sub lite?What part in a pre-sub do engineers play, say with regard to testing matrix?In September, we received guidance revisions with regard to the pre-sub. What was of significance in these revisions? You can review the pre-sub guidance discussed during the podcast