Serious adverse health consequences

This definition sets the scope of FDA device tracking (21 CFR 821) and postmarket surveillance ordered under section 522 (21 CFR 822). Devices whose failure would be likely to have such consequences can fall under these requirements.

Serious adverse health consequences means any significant adverse experience related to a device, including device-related events which are life-threatening or which involve permanent or long-term injuries or illnesses.

21 CFR, 821.3

Serious adverse health consequences means any significant adverse experience related to a device, including device-related events that are life-threatening or that involve permanent or long-term injuries or illnesses.

21 CFR, 822.3

Serious, adverse health consequences means any significant adverse experience, including those which may be either life-threatening or involve permanent or long term injuries, but excluding injuries that are nonlife-threatening and that are temporary and reasonably reversible.

21 CFR, 814.3