21 CFR 820.60 - Identification

What it says

Procedures must be established to identify products during all stages of receipt, production, distribution and installation, preventing mix-ups between different devices, components or lots and supporting accurate traceability throughout manufacturing.

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

What it means in practice

• Identification procedures under this provision are the practical mechanism that prevents the kind of mix-up that traceability and device history record requirements are ultimately designed to catch after the fact.
• For manufacturers producing multiple device variants or configurations on shared lines, identification control becomes especially critical since visually similar components or subassemblies are the most common source of mix-up risk.
• This provision works closely with acceptance status marking, since a device or component's identification often needs to convey not just what it is but whether it has passed the required inspections and tests.

What FDA inspectors look for

• Whether identification procedures are actually followed on the production floor, not just documented in a quality manual.
• Whether components or subassemblies that look similar across different device variants have distinct, reliable identification to prevent mix-up.
• Whether identification is maintained consistently from receipt through distribution, including during any staging or work-in-process storage.

Related regulations