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U.S. Department of Health and Human Services

For Industry

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Does my device need to be labeled? What information should be included in the labeling?

The general labeling requirements for medical devices are contained in 21 CFR Part 801. These regulations specify the minimum requirements for all devices. Later sections in this chapter discuss any additional requirements needed for specific categories of devices.

For more information on Device Labeling, please visit the Device Advice website.

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