FDA device class
Beginner
How risky the U.S. government rates a medical device. The riskier it is, the more proof it needs before it can be sold.
Novice
The U.S. Food and Drug Administration’s risk rating for a medical device: Class I (lowest risk), Class II, and Class III (highest risk). Class III devices, which include most implants, generally need premarket approval (PMA) before they can be sold.
Expert
Class sets the controls and pathway: general controls, special controls, and 510(k) clearance for most non-exempt Class I and II devices; PMA for Class III. Changes after approval then follow that pathway’s change rules.