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.
Under this guidance, mobile medical apps are subject to the same classification scheme and associated regulatory requirements of other FDA-regulated medical devices – class I (general controls), class II (special controls in addition to general controls), or class III (premarket approval). The FDA lists three categories of mobile medical apps over which it will exercise its regulatory authority:
- “Mobile apps that connect to an existing device type for purposes of controlling its operation, function, or energy source,” such as apps that control the inflation of a blood pressure cuff or insulin delivery;
- “Mobile apps that transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices,” such as “mobile app that uses the built-in accelerometer on a mobile platform to collect motion information for monitoring sleep apnea;” and
- “Mobile apps that become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations,” such as an app “that connects to cardiac monitors and transfers the data to a central viewing station for display and active patient monitoring.
The guidance lists various entities and apps that would not be regulated. This includes both apps that are not included in the definition of mobile medical apps and apps that are included in the definition but that pose only a minimal risk to patients. Entities who are not subject to oversight by the FDA include those who “distribute mobile medical apps without engaging in manufacturing functions” such as Google, Apple, and Amazon’s app stores. Similarly, the devices and platforms, for example iPhones and iOS, which are sold to consumers but not marketed as medical devices will not be subject to regulations governing mobile medical app manufacturers. Apps that are not defined as mobile medical apps include medical dictionary apps, interactive anatomy diagrams designed to educate consumers or train health care providers, and generic apps, like audio recording, when it is not specifically intended for medical use.
Finally, the FDA lists examples of mobile medical apps that pose minimal risks to patients, and from which it will refrain from regulating, including apps that use GPS location information to alert asthmatics of environmental conditions that may cause asthma symptoms, apps that tell users whether their drugs have any interactions with each other, and apps that use a checklist of common signs and symptoms to provide a list of possible medical conditions and advice on when to consult a health care provider.
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