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  1. FDA Basics for Industry

What must I do to import radiation-emitting products into the US?

As a manufacturer or importer of regulated radiation-emitting electronic products, you have certain reporting and recordkeeping responsibilities that are found at 21 CFR 1002

For more information on importing and exporting radiation-emitting products, please visit the ‘Importing and Exporting Electronic Products’.

Note: Electronic Products that are also Medical Devices are subject to the device provisions of the Federal Food, Drug, and Cosmetic Act. For more information, see Getting to Market with a Medical Device.