FDA Drafts Guidance on Mobile Applications

According to a recent Apple report, over 425,000 mobile apps are now available in the App Store, with a staggering 200 million users and 15 billion downloads. And recent reports show explosive growth in use of Google’s Android operating system, with over 550,000 new activations every day. The ubiquitous presence of mobile applications is not limited to games, however, as there are growing numbers of apps for medical conditions such as diabetes (there were over 700 at time of the recent ADA!). With this in mind, it’s not surprising that the FDA recently released a draft guidance document (the agency’s current thinking on a particular topic) detailing how it will apply regulatory requirements to a certain subset of mobile applications. The agency’s much-anticipated guidelines left many questions unanswered, but did confirm and extend a regulatory framework for mobile apps that diagnose or treat diseases, and applications that connect to other medical devices. Where the FDA hasn’t yet claimed a regulatory role, but reserves the right to do so, is with apps that help people track and manage their health through data manually (or automatically) entered by the users, including identifying glucose patterns and improving overall management. One much-anticipated application for people with diabetes in this space is from Massive Health, a startup company currently running a closed beta test with iPhone users (Massive Health first opened the beta to diaTribe users and we advertised it on Twitter for 24 hours before it filled up – in the future, if you’d like to participate in chances like this, follow @diaTribenews and @MassiveHealth). From what we've seen of Massive Health's app, it seems easy to use, and even fun and entertaining. Other applications in this category offer treatment recommendations to patients, like WellDoc’s DiabetesManager (see New Now Next in diaTribe #25). General health and wellness apps (e.g., exercise suggestions, calorie counters, or “brochure ware,” like the new myMedtronic Connect app) will not be subject to FDA oversight or regulation.We’ve previously covered apps that will now clearly be regulated, such as AgaMatrix/Sanofi’s iBGStar (a self-contained blood glucose meter that plugs into the iPhone; see New Now Next in diaTribe #25). Because the app directly reads data from a medical device, it requires FDA approval before marketing. We’ll look forward to helping cut through what apps might help different groups of people with diabetes, their caregivers, and their families in future issues. --AB/KC