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U.S. Department of Health and Human Services

For Industry

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What gives FDA the authority to regulate manufacturers of radiation-emitting electronic products?

The FDA’s statutory authority to regulate these products is granted by the United States Federal, Food, Drug and Cosmetic Act, Chapter V, Subchapter C, Electronic Product Radiation Control.

Title 21 of the Code of Federal Regulations, Subchapter J, Parts 1000 through 1050 (21 CFR 1000 – 1050) contains radiation safety regulations for manufacturers of radiation-emitting electronic products. Manufacturers are responsible for producing products that do not emit hazardous and unnecessary radiation. All manufacturers must comply with the applicable requirements in Title 21 CFR 1000, 1002, 1003, 1004 and 1005. If a mandatory radiation safety performance standard applies to a manufacturer’s product, then the manufacturer must also comply with Title 21 CFR 1010 and the product must comply with the requirements of the standard. Mandatory radiation safety performance standards are found in 21 CFR 1020 – 1050.

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