Expected life of a device

The expected life helps judge whether a failure reported in a US Medical Device Report happened prematurely. Some implants carry an end-of-life date, while for many devices the expected life depends on maintenance, repairs and upgrades.

Expected life of a device means the time that a device is expected to remain functional after it is placed into use. Certain implanted devices have specified “end of life” (EOL) dates. Other devices are not labeled as to their respective EOL, but are expected to remain operational through activities such as maintenance, repairs, or upgrades, for an estimated period of time.

21 CFR, 803.3