FDA to take 'tailored policy' to mobile medical app regulation

Agency issues guidance on growing market

SILVER SPRING, Md. — The Food and Drug Administration will not enforce regulatory requirements for most mobile medical apps because they "post minimal risk to consumers," the agency said Monday.

The FDA announced the issuance of guidance on the apps, saying it would adopt a "tailored policy" toward regulation, focusing its regulatory oversight on those apps that present greater risk if they do not work as intended.

"Some mobile apps carry minimal risks to consumers or patients, but others can carry significant risks if they do not operate correctly," FDA Center for Devices and Radiological Health director Jeffrey Shuren said. "The FDA's tailored policy protects patients while encouraging innovation."

As examples, the FDA cited apps that can allow doctors to diagnose patients with potentially life-threatening conditions outside traditional healthcare settings, as well as helping consumers manage health and wellness, including some that can diagnose abnormal heart rhythms, allow smartphones to function as mobile ultrasound devices or function as the "central command" for a diabetic patient's glucose meter.

As such, the FDA said it would focus on apps that are intended for use as accessories for regulated medical devices or that transform smartphones and other mobile devices into medical devices. Mobile apps subject to FDA review would undergo the same regulatory processes as other medical devices.

"We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly," Shuren said. "Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products."

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