FDA Issues List of Device Premarket Notification Exemptions

The FDA released a final order that removes premarket notification requirements for certain class I and II devices.

The exemptions, some of which come with limitations, apply to a range of different products, including drug testing devices and coagulation systems.

For example, the action only exempts cocaine and cocaine metabolite test systems from premarket notification procedures if they are intended for employment and insurance testing and state that on the labeling.