FDA September 26, 2018
When the Food and Drug Administration recently granted marketing authorization 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...
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