The FDA released the (currently non-binding) “Draft Guidance for Industry and Food and Drug Administration Staff on Mobile Medical Applications“last week.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.
To read the full, original article click on this link: Mobile medical apps: Here’s how the FDA defines them, what it excludes
Author: Shahid Shah
