FDA Issues Draft Guidance on Mobile Medical Apps Does the App Present a Risk to Patients if it Does Not Function as Intended?

On July 19, 2011, the U.S. Food and Drug Administration (FDA or the Agency) released a “Draft Guidance for Industry and Food and Drug Administration Staff” on “Mobile Medical Applications.” The draft announces FDA’s intention to regulate mobile applications (apps) that “either have traditionally been considered medical devices or affect the performance or functionality of a currently regulated medical device.” According to Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health (CDRH), “[FDA’s] draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.”1 Although FDA acknowledged that this proposed approach “does not cover the majority of medical apps,”2 its scope is broad. Public comments on the draft Guidance may be submitted online or in writing through October 19, 2011.3

I. The Scope of the Draft Guidance

The draft Guidance defines three key terms:

- “Mobile platforms” are “commercial off-the-shelf (COTS) computing platforms, with or without wireless connectivity, that are handheld in nature.” Examples include smartphones, tablet computers, and personal digital assistants (PDAs).

- A “mobile application” or “mobile app” is a “software application that can be executed (run) on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server.”

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