Device Classification (US)

The FDA's three classes for devices, set by whether general or special controls give reasonable assurance of safety and effectiveness. Class I needs general controls only. Class II needs special controls as well. Class III needs premarket approval.

Classes and criteria

Class I

General controls give reasonable assurance of safety and effectiveness. A device also falls here when information is too thin to set controls. The device must not be life-supporting or life-sustaining, of substantial importance in preventing impairment of health, or a potential unreasonable risk of illness or injury.

Class II

General controls alone are not enough, and enough information exists to set special controls such as performance standards, postmarket surveillance, patient registries, and guidelines.

Class III

Neither general nor special controls are shown to give reasonable assurance. The device is also life-supporting or life-sustaining, of substantial importance in preventing impairment of health, or a potential unreasonable risk of illness or injury. Premarket approval is required.

Where it is written

21 CFR 860.3(c)

Also called

Class I device, Class II device, Class III device, FDA device class

Related terms