When you hear the term “App” in reference to an iPhone, iPad, or other smartphone/tablet devices, what pops into your head? If “Angry Birds” (a wildly popular downloadable game) or “Facebook” first comes to mind, then you haven’t been living in a dark, sequestered hole for the past few years since smartphones hit the market and apps began to dominate popular culture. However, the Health industry has proven that mobile applications can be used for far more useful tasks than flinging birds or checking out what your friends did over the weekend. Several health-related apps have been developed to achieve a plethora of different tasks, from turning a mobile device into an electronic stethoscope to tracking blood sugar levels and viewing X-ray results. FDA already regulates such traditional medical devices that perform the aforementioned tasks, so why shouldn’t they regulate apps on mobile devices that execute the same duties?
FDA’s July 21st released “Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications” (see the full Draft Guidance here) defines such terms as “Mobile Application” and “Mobile Medical Application.” A mobile app is defined as a “software application that can be executed (run) on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server.” A mobile medical app meets FDA’s definition of a “device” in addition to either being “used as an accessory to a regulated medical device,” or “transforms a mobile platform into a regulated medical device.” An article by The Washington Post entitled “FDA moves to regulate mobile health applications” states the concern of some people within the industry who fear that FDA “may not be able to effectively monitor mobile and information technology products because they evolve more quickly than other medical devices.” Jeff Shuren, director for FDA’s Center for Devices and Radiological Health, assures that the agency will take a more adaptive approach when reviewing such apps due to the always evolving nature of mobile health apps. For instance, a product’s safety could be proven by the software manufacturer rather than through trials in a clinical setting, which would greatly reduce the time necessary to review the app. Though such reviews may come as an inconvenience to manufacturers and users alike, the safety of all individuals involved with mobile health apps is at the heart of FDA’s newly proposed guidance.