U.S. medical device regulators at the Food and Drug Administration (FDA) have proposed exempting hundreds of moderate-risk devices from 510(k) premarket notification requirements as the agency begins implementing components of the 21st Century Cures Act passed in late 2016.
Explaining the latest round of proposed Class II device exemptions, the agency stated that removing 510(k) requirements for these products will allow the agency to refocus resources on premarket reviews of devices that pose greater public health risks. Among other things, the 21st Century Cures Act requires the agency to identify Class II device types for which reviewers no longer need reports of reasonable assurances of safety and effectiveness in order to grant clearance for the US market.
