New FDA Draft Guidance on Mobile Medical Apps Provides Some Clarity, But Raises Many More Questions


On July 19, the Food and Drug Administration (FDA) issued a new draft guidance document, titled Mobile Medical Applications, describing FDA’s position on the regulation of mobile applications, i.e., software applications intended to run on mobile platforms, such as smart phones, personal digital assistants, tablets, and other mobile computing devices. FDA stated that its proposed approach is intended to focus only on a small subset of mobile applications, or “apps,” that may impact the performance of currently regulated devices. To this end, the draft guidance provides some principles to apply and examples of the types of mobile apps that would be considered regulated medical devices. However, a number of uncertainties remain as to exactly where FDA draws the line between regulated and unregulated apps. Thus, although FDA stated intention is to concentrate on those mobile apps that present the greatest risk to patients, ambiguities in the draft guidance may hinder that objective.

In the new draft guidance, FDA defines a “mobile medical app” as a mobile app that (1) meets the definition of a “device” under the Federal Food, Drug, and Cosmetic Act (FFDCA) and (2) either (a) is used as an accessory to a regulated medical device or (b) transforms a mobile platform (such as a mobile phone) into a regulated medical device.

FDA states in the draft guidance that it intends to limit its regulation of mobile apps to those that fall within the definition of a “mobile medical app,” and that it would exercise enforcement discretion for other mobile apps that meet the definition of a “device” under the FFDCA but do not meet the definition of a “mobile medical app.”

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