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HHS, FDA Backtrack From Plan to Deregulate mHealth Devices, Apps
mHealth Intelligence April 22, 2021
The federal agencies are reversing course after a Trump administration proposal to end oversight of dozens of mHealth apps, devices and platforms drew strong opposition from within and outside government.
Federal officials are quietly withdrawing a Trump administration plan to end regulatory review of 83 types of mHealth devices, saying the original plan was flawed and could have put the lives of Americans using that technology in danger.
In a notice posted last week in the Federal Register, the Health and Human Services Department and the Food and Drug Administration announced that they won’t enforce an HHS notice posted on January 15 that, among other things, would have exempted 83 class II devices and one unclassified device from premarket notification....
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