C. Mobile Medical Application (Mobile Medical App)
For purposes of this guidance, a "mobile medical app" is a mobile app that meets the definition of "device" in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)4; and either:
- is used as an accessory to a regulated medical device; or
- transforms a mobile platform into a regulated medical device.
One example is a light emitting diode (LED) included on a mobile platform with a mobile app to make that LED operate. If the manufacturer intends the system to illuminate objects generally (i.e., without a specific device intended use), neither the mobile app nor the mobile platform would be considered medical devices. If, however, through marketing and distribution, the mobile app is promoted by the manufacturer for use as a light source to examine patients, then the mobile app would meet the definition of a device. (In this case, the intended use of the light source would be similar to a conventional device such as an ophthalmoscope.)
In general, if a mobile app is intended for use in performing a medical device function it is a medical device, regardless of the platform on which it is run. For example, mobile apps intended to run on smart phones to analyze glucose meter readings would be considered similar to software running on a desktop computer, which is regulated under 21 CFR 862.1345 ("glucose test system").
You can read the FDA Draft Guidance document here.