FDA Proposal Would Lower Requirements for Some Moderate-Risk Devices

Over three-hundred class II medical devices made the list of those that might become exempt from premarket notification requirements once the FDA takes final action.

The Food and Drug Administration March 14 published a proposed list of class II devices that will be exempt from the requirements, also called 510(k)s, when the list is made final (82 Fed. Reg. 13,609). Class II devices are moderate-risk devices. A 510(k) clearance demonstrates that a device is substantially equivalent to another (or predicate) device already on the market. Clinical data typically aren’t generated for a 510(k).

The 21st Century Cures Act ...