Rock Health’s guide to FDA for the health tech entrepreneur (US)

In 26 slides, Rock Health has neatly summarized for those unfamiliar with the FDA approval thickets (99% of us) on what is a regulated health tech product and is not. Instead of a MEGO (my eyes glaze over) experience (familiar to all those who’ve sledded through the FDA website), there are simple examples in how to determine what class your device falls into (I, II, III) and what you need to do to gain approval. It also clearly defines the substantial difference between 510(k) premarket submission and the far more complicated PMA premarket approval–and the fact that after approval, FDA will forever be in your life. It also notes that other approvals such as FCC may be required and many other tips on how to make the process easier and less garment-rending for your organization. Features comments from Chris Bergstrom of WellDoc and Geoff Clapp, who co-founded Health Hero which is now Bosch Health Buddy. SlideShare link

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