Mobile application (mobile app)

Being an app says nothing on its own about regulation. FDA looks at the function the app performs, and only apps with functions that meet the device definition, and are not under enforcement discretion, are treated as mobile medical apps.

For purposes of this guidance, a mobile application or “mobile app” is defined as a software application that can be executed (run) on a mobile platform (i.e., a handheld commercial off-the-shelf computing platform, with or without wireless connectivity), or a web-based software application that is tailored to a mobile platform but is executed on a server.

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