Class III

Class III devices usually need a PMA, which requires clinical evidence of safety and effectiveness. Some older class III device types are still cleared through 510(k) until FDA calls for PMAs, which is where the class III summary and certification come in.

Class III means the class of devices for which premarket approval is or will be required in accordance with section 515 of the Federal Food, Drug, and Cosmetic Act. A device is in class III if insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness, or that application of special controls described in the definition of “Class II” in this section in addition to general controls, would provide such assurance, and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury.

21 CFR, 860.3