FDA Releases Draft Guidance on Mobile Medical Applications

The FDA has released a Draft Guidance document on Mobile Medical Applications. Here's a snippet regarding the definition of a "mobile medical app" here:

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.

The intended use of a mobile app determines whether it meets the definition of a "device." As stated in 21 CFR 801.4,5 intended use may be shown by labeling6 claims, advertising materials, or oral or written statements by manufacturers or their representatives. When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a 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You can read the FDA Draft Guidance document here.