Device failure

In 21 CFR 821 and 822 the term applies to tracking and postmarket surveillance. It overlaps with malfunction under the reporting rules, but each regulation uses its own term.

Device failure means the failure of a device to perform or function as intended, including any deviations from the device's performance specifications or intended use.

21 CFR, 821.3

Device failure means a device does not perform or function as intended, and includes any deviation from the device's performance specifications or intended use.

21 CFR, 822.3