On September 25, 2013, FDA issued a final Guidance for Industry and Food and Drug Administration Staff entitled, "Mobile Medical Applications". This Guidance discusses FDA's intention to oversee the use of mobile applications ("apps") that qualify as medical devices and that pose a risk to the user if they do not function as intended. These "mobile medical apps" meet the definition of a medical device, and are either intended "to be used as an accessory to a regulated medical device; or transform a mobile platform into a regulated medical device." Section 201(h) of the Federal Food, Drug and Cosmetic Act ("FD&C Act") defines a device as
[A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is . . . [I]ntended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or . . . [I]ntended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
FDA places mobile medical apps in the same category of risk as currently regulated devices and intends to regulate them in the same way. The Guidance aims to assist manufacturers in determining whether a product qualifies as a mobile medical app and, if so, provides FDA's regulatory requirements. FDA sets forth three types of mobile medical apps that it intends to apply regulatory oversight to:
- Mobile apps that connect to medical devices and are extensions of these devices that control, display, store, analyze, or transmit data from the medical device.
For example: an app that controls the delivery of insulin by transmitting signals to an insulin pump.
- Mobile apps that transform the mobile platform into a regulated medical device.
- Mobile apps (software) that perform patient-specific analyses and then provide patient-specific diagnoses or treatment recommendations.
For example: an app that attaches electrocardiogram electrodes to a mobile platform to measure, store, and display electrocardiogram signals.
For example: an app that calculates radiation dosages or creates dosage plans for radiation therapy