26 September 2018 - When the FDA recently granted marketing authorisation for two medical apps for Apple’s new Watch, it marked a significant step forward for the agency’s overall approach to the development of digital health.

As described in existing guidance, the FDA generally reviews medical apps without reviewing the general purpose computing platform they sit upon, such as a phone. Similarly here, the FDA reviewed the apps intended for a medical purpose, in this case to identify possible atrial fibrillation, as medical devices, and did not review the underlying general purpose hardware, in this case a sensor, on which they sit and draw their functionality. 

But the difference was that that phone didn’t have a heart monitor sensor built into it to generate an ECG. The new watch did. With the watch, what we said was simple: sensors that are general purpose can also be decoupled from review of a medical app and we wouldn’t regulate or turn the entire platform into a medical device, just to enable a platform to host software with medical functionality. And the policy we advanced was to say that only the apps intended for a medical purpose, in this case to identify possible atrial fibrillation, would be reviewed and cleared as medical devices.

Read FDA blog