Pre-Sub with the FDA

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...