Many have asked me for an analysis of the new FDA Mobile Medical Applications NPRM.
The FDA will not seek to regulate mobile medical apps that perform the functionality of an electronic health record system or personal health record system. However, the FDA defined a small subset of mobile medical apps that may impact the functionality of currently regulated medical devices that will require oversight. Here’s a thoughtful analysis by Bradley Merrill Thompson of Epstein Becker Green, which he has given me permission to post:
“Today, FDA published the long-anticipated draft guidance on the regulation of mobile apps—more specifically, what the agency calls “mobile medical apps”. This draft reflects significant efforts by FDA in a fairly short amount of time, and we applaud that work. Much of the framework of the FDA guidance is consistent with the work the mHealth Regulatory Coalition (MRC) published on its website earlier this year (www.mhealthregulatorycoalition.org). While FDA has done a good job getting the ball rolling, there are a number of areas that require further work. We all (including FDA) recognize that this draft guidance is certainly not the end of the story.
The regulatory oversight recommended in today’s draft guidance applies only to a small subset of mobile apps, which FDA defines as any software application that runs on an off-the-shelf, handheld computing platform as well as web-based software designed for mobile platforms. To be regulated, as a first step the app would have to first meet the definition of a medical device and then as a second step either (1) be used as an accessory to another regulated device or (2) “transform” the handheld platform into a device, such as by using the platform’s display screens or built-in sensors.