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U.S. Department of Health and Human Services

For Industry

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How can I find out if my product is regulated by CDRH? (Radiation)

The U.S. Food and Drug Administration (FDA) develops and carries out a national program designed to control unnecessary exposures to, and assure safe and efficacious use of, ionizing and non-ionizing radiation-emitting electronic products. The Center for Devices and Radiological Health (CDRH) is the component within the FDA that is responsible for this program. The FDA's legal authority to regulate electronic radiation-emitting products is the Federal Food Drug & Cosmetic (FD&C) Act.

For more information, please visit the Device Advice website.

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