Mobile medical application (mobile medical app)

FDA focuses its oversight on these apps because a malfunction could put patients at risk. Many other health apps fall outside the device definition or under enforcement discretion, so the claims made for the app decide where it lands.

For purposes of this guidance, a “mobile medical app” is a mobile app that incorporates device software functionality that meets the definition of a device in section 201(h) of the FD&C Act; and either is intended: • to be used as an accessory to a regulated medical device; or • to transform a mobile platform into a regulated medical device.

FDA guidance: Policy for Device Software Functions and Mobile Medical Applications (September 2022), Section III.C, Definitions