On September 25, 2013, the U.S. Food and Drug Administration (“FDA”) released final guidance on how it intends to regulate mobile applications (“apps”). The guidance consists of a set of nonbinding recommendations that define what mobile apps meet the definition of a medical device and are therefore subject to FDA’s regulation as medical devices and what mobile apps fall outside the definition of a medical device. Perhaps the most important portion of the guidance is the FDA’s clarification of how it will “exercise its enforcement discretion” and specifically what apps it will refrain from regulating as medical devices and what apps the FDA will be regulate as medical devices. The genesis of this guidance in part was concern that popular apps sold by various online app sellers for weight management and other apps that assist consumers in self managing their disease conditions would turn cell phones and tablets into medical devices thereby subjecting the app developers, carriers and sellers to FDA regulation as device manufacturers and marketers.
Broadly, the key determination as to whether an app is considered a medical app is the intended use of the app; “when the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device” and subject to FDA oversight. Specifically, a mobile medical app is an app that both meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and is also intended to either “be used as an accessory to a regulated medical device; or transform a mobile platform into a regulated medical device.” Under the FD&C Act intent is determined by marketers advertising and marketing claims for the product.
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We would like to thank Sharon Blinkoff for her contribution