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…assuming it’s a mobile medical app. In a draft guidance released last week, the Food and Drug Administration (FDA) announced and clarified its intent to regulate certain “mobile medical apps” in accordance with already extant federal regulations. Now before you sound the alarms, the Angry Birds and Black’s Law Dictionary apps are – shockingly, I know – not considered mobile medical apps. Instead, the FDA is (smartly, I may add) looking to define certain mobile apps as mobile medical apps if they fit the definition of “device” within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which states:
(h) The term “device” (except when used in paragraph (n) of this section and in sections 301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is–
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended 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
(3) intended 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.
In addition to pegging the mobile medical application definition firmly to a central definition of the FD&C Act, the draft guidance will require that a mobile app is either “used as an accessory to a regulated device” or “transforms a mobile platform into a regulated medical device.” Given the current regulatory landscape, this definition properly cabins what will be termed a mobile medical app to those mobile apps that replicate or add to the functionality of what a typical patient would consider a medical device in the real world (think electrocardiogram or electroencephalogram machine).
Given the increasing popularity of mobile platforms like iOS and Android and the apps that power them, this definition could help to stave off hand-wringing (re: litigation) by developers and mobile device makers alike (not to mention hilariously uninformed online commenters). This leaves popular every day apps like calorie counters, pill reminders, and Nike+ out of the purview of any regulations currently on the table.
Regulating mobile medical apps just makes sense. Simply because the apps (or hardware peripherals) are written for a consumer product designed by Apple or Samsung does not mean that apps are inherently safe. In fact, given the low bar to admission and the relative affordability of development, they may be potentially more dangerous. Considering that many of these apps replicate the complicated and important functionality of traditional (FD&C Act regulated) medical devices, there is little reason to leave these apps unregulated. In fact, regulation could actually help spur development by increasing the potential market through instilling confidence among medical professionals in the functionality of the apps.
However, if you take issue with the draft guidance or are worried that the FDA will rip Angry Birds from your thumbs, you have less than ninety days to let the FDA know.
– David Rutenberg