FDA Finalizes Long-Sought Mobile Medical Apps Guidance

Law360, New York (September 23, 2013, 3:26 PM EDT) -- The U.S. Food and Drug Administration on Monday unveiled highly anticipated final guidance on how it will regulate the burgeoning field of mobile medical apps, outlining a largely hands-off approach and providing specifics regarding the types of entities and software it will police.

Agency officials, long pressed by lawmakers not to stifle innovation, had signaled for some time that they would apply a light touch to apps, and Monday’s guidance cemented that promise, saying only a narrow category of apps will fall under FDA purview....
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