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US FDA Issues Draft Regulatory Guidelines For Mobile Medical Apps

With the increasing number of medical and health care related apps making their way on smartphones and other portable devices (tablets, media players etc), the US Food and Drug Administration has issued Draft Guidances for bringing certain Mobile Medical Apps into the regulatory regime, seeking feedback from the medical industry and the FDA Staff. This is a sign of things to come - with an increased focus on mobile health related services in India, undoubtedly, mobile initiatives in India will also come under regulatory scrutiny. Regulators in the country are waking up to the impact of digitization: for example, the insurance regulator IRDA issued draft guidelines regarding web aggregators of insurance services earlier this year. The guidelines from the US FDA for medical mobile apps should be seen as a pointer for something that might happen in India, perhaps a couple of years from today (if not sooner): What The US FDA Is Seeking To Regulate The guidelines cover only select apps that are critical to or impact the performance or functionality of currently regulated medical devices, and app developers whose apps qualify as a medical app as per the FDA's definition, would be under close watch of the authority. App distribution platforms such as app stores are expected to cooperate with app developers in conducting corrections and removals. Although the draft guidance does not establish legally enforceable responsibilities, it does require the manufacturers i.e developers to annually register their establishments with the FDA and provide a list of devices/apps they…

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