Draft Guidance Clarifies How FDA Plans To Regulate Certain Software “Apps”


On July 21, 2011, the Food and Drug Administration (“FDA”) issued a draft guidance document describing how it intends to apply its regulatory authority to certain software applications intended for use on mobile platforms, which the agency terms “mobile medical applications” or “mobile medical apps.” FDA believes that mobile medical apps pose the same or similar safety risks as currently regulated devices performing the same functions. Accordingly, a mobile medical app manufacturer, which includes a person that initiates specifications for an app, will be subject to the medical device regulation. Under the draft guidance, parties to a software development agreement can define their respective regulatory obligations by contract.

Mobile Medical Apps

The draft guidance defines a “mobile app” as a software application that runs on a mobile platform, such as an iPhone®, BlackBerry®, smart phone, or tablet computer. A mobile medical app is a mobile app that meets the definition of “device” in the Federal Food, Drug, and Cosmetic Act and is either an accessory to a regulated medical device or transforms a mobile platform into a regulated medical device.

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