Device Week Podcast – Episode 2
This article was originally published in The Gray Sheet
Executive Summary
This week, "Gray Sheet" reporters and editors discuss CDRH's new pediatric chief medical officer, the first device firm to announce participation in FDA's Expedited Access Pathway, a novel point-of-care molecular diagnostic platform, debunking federal courts' "20-hour 510(k)" position and more regulatory and business topics of interest to the device and diagnostics community.