There’s an App for That”— FDA’s Guidance on Mobile Medical Applications

With the market for healthcare apps to “quadruple to $400 million by 2016,” it should be no surprise that the Food and Drug Administration (FDA) plans to regulate these emerging mobile technologies.[i] Changing how consumers interact with the healthcare system and the increasing market growth, healthcare mobile apps are requiring the FDA to take a regulatory stance on these new platforms. On September 25, 2013, the FDA released Mobile Medical Applications:  Guidance for Industry and Food and Drug Administration Staff which outlines their plan for regulating mobile apps (Guidance).[ii].

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