21 CFR 820.120 - Device Labeling

What it says

Device labeling must be controlled to ensure correctness, legibility and proper application, with procedures addressing labeling storage to prevent mix-ups, deterioration or damage, and verification that the correct labeling is used for each specific device before release.

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

What it means in practice

• This provision addresses labeling as a quality system control point distinct from the content requirements in 21 CFR Part 801, focusing on preventing the physical mix-up of labeling between different device models or configurations during production.
• Facilities producing multiple device variants with similar packaging are at particular risk here, since a labeling control failure can result in correctly manufactured devices shipped with the wrong label.
• Label storage conditions matter because labeling that deteriorates or becomes illegible before use can itself become a quality system control failure, not just a cosmetic issue.

What FDA inspectors look for

• Whether labeling control procedures actually prevent mix-ups between similar labeling used for different device variants on the same production line.
• Whether a documented verification step confirms the correct labeling was applied to each specific device before release.
• Whether labeling storage conditions are controlled to prevent deterioration or damage prior to use.

Related regulations