US mHealth Regulation – Playing Peek-a-Boo with the FDA
Join HTF for our monthly meeting on February 19th in SF as our panel of experts examine the recently released FDA guidance on mHealth applications and discuss the issues with navigating the evolving regulatory landscape.
In September 2013, the FDA published its final guidance on mHealth regulation. The FDA classified the range of mobile health apps into three categories. At one end are apps that essentially look and act like traditional medical devices which will be actively regulated by the FDA and require pre-market clearance. At the other end are apps that could be considered non-medical use and will not be regulated. The vast majority of interesting mHealth apps will be subject to “enforcement discretion” since they fall somewhere in-between. In other words, the FDA will probably not actively regulate this kind of app, but will instead reserve the right to do so. An interesting consideration for this category is how to provide the maximum patient benefit without getting on the FDA’s radar. Alternately, there might be some benefits in embracing regulation for strategic reasons.