FDA’s New Draft Guidance on Mobile Apps and What It Means to Health IT Vendors

The FDA released the (currently non-binding) “Draft Guidance for Industry and  Food and Drug Administration Staff on Mobile Medical Applications” earlier this week. I knew many of my clients and readers would be asking about the ramifications of this new guidance so I read the document as soon as it came out. In general I was impressed by the FDA’s balanced approach to patient safety and their desire not to stifle competition; overall I thought they were not looking to overreach their purview and I think they succeeded (except for the part on clinical decision support, discussed further below).

Unlike many regulations that come out of DC, this guidance document is quite readable by us mere mortals: it’s written in plain English  and not legal-speak so I recommend picking up a copy, setting aside 30 minutes, and going through it (if you’re on the beach, it’s great reading).

In case you’re not from DC (like me) and don’t spend your days around a bunch of govies (like I do) I wanted to let you know how big a step this is for the FDA. They’re taking a public stand about what they know and what they think are grey areas and I for one commend them for putting this document out.

The first 12 or so pages are preambles, definitions, and other important but not particularly fun reading. The real meat starts on page 13 with the “Mobile medical apps for which FDA will apply regulatory oversight” section and is probably a good place to start if you’re looking to skim the guidance.