Table 2: Three Tier Device Control System

Class	Description
I	devices for which General Controls including manufacturer registration and product listing with the FDA are adequate to ensure safety and effectiveness
II	devices for which General Controls are inadequate and special controls(i.e. standardized testing protocols, bench-testing or clinical data) are required to provide assurance
III	entirely new post-amendment devices, or devices with a new design, or new intended use, or devices found Not Substantially Equivalent (NSE) to pre-amendment devices for which there is insufficient information to assure their safety and effectiveness