Mobile platform

FDA does not regulate the makers of phones and tablets because their general-purpose platforms can run medical apps. The app manufacturer is responsible, including for showing that the app works on the platforms it supports.

For purposes of this guidance, “mobile platforms” are defined as commercial off-the-shelf (COTS) computing platforms, with or without wireless connectivity, that are handheld in nature. Examples of these mobile platforms include mobile computers such as smart phones, tablet computers, or other portable computers.

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