A US FDA guidance document issued Feb. 8 removes 510(k) requirements for 10 device types, including hearing protectors, hemorrhoid cushions and spine curvature monitors.
It is the latest in a series of 510(k)-exemption announcements from the agency under the authority of the 2016 21st Century Cures Act, which gave the agency greater authority to drop 510(k) requirements on well-understood class I and II devices
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