21 CFR 820.80 - Receiving, In-Process and Finished Device Acceptance

What it says

Incoming product must be inspected, tested or otherwise verified for conformance to specified requirements, in-process product must be controlled until required inspections and tests have been completed, and finished devices must not be released for distribution until all required activities have been completed and the data reviewed.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This provision covers the full acceptance chain, receiving, in-process and finished device, meaning a gap at any one stage, not just final release, can allow a nonconforming device to move forward.
• In-process acceptance activities are what catch a developing nonconformance before it becomes embedded in a finished device, making them a meaningfully different control than final inspection alone.
• Finished device release decisions under this provision must be based on a documented review of acceptance data, not simply on the absence of any flagged problems during manufacturing.

What FDA inspectors look for

• Whether receiving acceptance activities were actually performed and documented before incoming product was used in production.
• Whether in-process acceptance activities were completed at the defined points before product moved to the next manufacturing stage.
• Whether finished device release records show a documented review of acceptance data, rather than release based on the absence of a reported problem alone.

Related regulations