21 CFR Part 801 - Medical Device Labeling

What it says

Medical device labeling must include specific required information, such as the name and place of business of the manufacturer, adequate directions for use, and any required warnings, and must not be false or misleading in any particular.

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

What it means in practice

• Labeling in this context covers far more than the physical label on a device, it extends to package inserts, instructions for use and, in many cases, promotional labeling that accompanies the device.
• A labeling change, even one that seems purely cosmetic, can trigger a need to reassess whether the device remains within its cleared or approved indications for use.
• Adequate directions for use is a substantive standard, not a formality, meaning instructions must actually be sufficient for the intended user to use the device safely and effectively.

What FDA inspectors look for

• Whether the labeling in current use matches the labeling that was cleared or approved for the device, with no unapproved changes to indications, warnings or instructions.
• Whether labeling control procedures prevent an outdated or incorrect label version from being used in production.
• Whether device labeling correctly reflects the specific model, configuration or software version being shipped, particularly for devices with multiple variants.

Related regulations