RAPS

FDA Finalizes List of 1,003 Class II Device Types Exempt From 510(k) Requirements

The US Food and Drug Administration (FDA) on Monday finalized a list of 1,003 types of class II medical devices that the agency believes do not present risks that require premarket notification review ...
RAPS

FDA Proposes Additional Class II Devices to be Exempt From 510(k) Requirements

Thanks to the 21st Century Cures Act, the US Food and Drug Administration (FDA) on Thursday proposed to exempt additional class II medical devices under five different product codes from 510(k) ...