Life-supporting or life-sustaining device

In US classification (21 CFR 860), a device for a use in supporting or sustaining human life points toward class III. The label also has consequences after market entry, since such devices can fall under device tracking and postmarket surveillance orders when used outside device user facilities.

Life-supporting or life-sustaining device means a device that is essential to, or that yields information that is essential to, the restoration or continuation of a bodily function important to the continuation of human life.

21 CFR, 860.3