Routine servicing

Routine servicing is excluded from correction and removal reporting under 21 CFR 806. The exclusion is narrow: unexpected repairs, early part replacement and identical fixes across several units are not routine.

Routine servicing means any regularly scheduled maintenance of a device, including the replacement of parts at the end of their normal life expectancy, e.g., calibration, replacement of batteries, and responses to normal wear and tear. Repairs of an unexpected nature, replacement of parts earlier than their normal life expectancy, or identical repairs or replacements of multiple units of a device are not routine servicing.

21 CFR, 806.2