As we can see the definition of labelling is very broad and if the product is mislabeled it is considered misbranded and misbranded product may need to be recalled.

Labelling regulations go beyond Good Manufacturing Practices, or 21CFR820.

Several Guidance’s

For General Device labelling 21CFR801 applies, for In Vitro Diagnostic products 21CFR809 applies, and for Investigational Device Exemptions (devices being investigated under clinical studies) 21CFR812 applies.

In addition, there are several guidance’s from the FDA that are applicable to medical device labelling, including:

• The “Device Labelling Guidance”
• “Labelling – Regulatory Requirements for Medical Devices”
• “Alternative to Certain Prescriptive Device Labelling Requirements”
• And “User Labelling for Devices that Contain Natural Rubber”