Is Your HIT App Subject to FDA Regulation? FDA Issues Final Guidance on Mobile Medical Apps

The U.S. Food and Drug Administration (the “FDA”) has issued long-awaited final guidance for the mobile medical applications (“Apps”) industry and FDA staff (the “Guidance”). The Guidance notes that it contains guidance only and that the recommendations included in the Guidance do not establish legally enforceable responsibilities; however, App developers should act quickly to determine if their Apps in the market or the pipeline will face regulatory scrutiny and regulation. Some Apps easily meet the definition of a “medical device” under Section 201(h) of the Federal Food, Drug and Cosmetic Act (“FD&C Act”) as they could pose a risk to patient safety if the Apps do not function as intended, while other Apps potentially fall within the definition of a “medical device” but pose lower risks and therefore should be subject to a lower level of regulation. The Guidance seeks to provide clarity and predictability on the FDA’s current approach to exercising its enforcement discretion.

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