EUO
Employment & Insurance Tests
Under the 21st Century Cures Act, the Food and Drug Administration (FDA or Agency) has identified a list of class II devices that are exempt
or no longer require premarket notification under section 510(k) of the FD&C Act. The devices listed below no longer require premarket
notification and can be used for Employment and Insurance Use. However, these devices may not be used for Federal drug testing programs
