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The Food and Drug Administration has finalized its guidance clarifying the agency’s hands-off approach to regulating mobile devices and apps. The agency has issued two documents outlining its position on medical device data systems and mobile medical applications, including those on smart phones. The documents reiterate the agency’s position that it won’t oversee low-risk medical devices, or will regulate them under a lower-risk classification. “Through smart regulation we can better facilitate innovation and at the same time protect patients,” the agency said.
The agency will, however, regulate mobile apps or devices intended to detect life-threatening conditions. “FDA’s oversight approach to mobile apps is focused on their functionality, just as we focus on the functionality of conventional devices,” the agency said. “Our oversight is not determined by the platform.”
(The documents are largely unchanged from draft versions.)