Medtech Matters

In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s announcement of their effort to modernize the 510(k) regulatory pathway. This podcast is an extension of the MPO January/February Editor’s Letter on the same topic. (Click here to read that Editor's Letter.) Specifically, we address a number of questions, including:Late last year, the FDA announced their efforts to modernize the 510(k) clearance pathway. Predicate devices seems to be a focal point. Is there a reason for the agency to seek to cut off the predicate device at 10 years or is that really just an arbitrary number they selected?If we were to cut off predicate devices at a certain time from being used, are we doing a disservice to all stakeholders involved? Do older predicate devices still offer advantages to the regulatory approval process?Is this a reactionary move to the bad press the FDA (and industry as a whole) suffered last year, such as the release of the findings from the Internation