FDA plan a ‘huge’ boost for mHealth
In a move that’s being lauded by mobile health innovators, the U.S. Food and Drug Administration has released dozens of mHealth medical devices from the requirements of added regulation.
The 12-page document issued Aug. 1 is part of the FDA’s draft guidance for the regulation of mobile medical devices and apps. In this latest posting, the FDA has proposed that it will not require premarket submission requirements from certain Class I and II medical devices under the reserved criteria of section 501(I) of the Federal Food, Drug and Cosmetic Act of 2012.
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