PMA (premarket approval)
Beginner
The strictest U.S. approval for medical devices. It is used for the riskiest ones.
Novice
The FDA’s strictest review, used for the highest-risk (Class III) devices. The maker must show evidence that the device is safe and effective before it can be sold.
Expert
After approval, any change affecting safety or effectiveness, explicitly including changes to circuits, components, physical layout and manufacturing facility, requires an approved PMA supplement before it is implemented.
Explained in Medical devices (Industries).