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U.S. FDA Radiation-Emitting Electronic Device Regulations

Radiation-Emitting Electronic Devices

Every manufacturer of electronic products, prior to offering such product for importation into the United States, must designate a U.S. Agent for service of processes. In addition, some manufacturers, assemblers, or importers may be required to provide additional Product Reports to FDA.

Registrar Corp can serve as your U.S. Agent for service of process and assist with submission of Product Reports, if required.

Radiation-Emitting Electronic Device Reporting

FDA requires reports to be submitted by manufacturers, importers, dealers, or distributors for most types of Radiation-Emitting Electronic Devices.

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Radiation-Emitting Electronic Device Labeling and Product Review

Registrar Corp helps companies determine whether their products may be considered a Radiation-Emitting Electronic Device by FDA. For products that are likely considered a Radiation-Emitting Electronic Device, Registrar Corp provides guidance regarding applicable FDA labeling requirements and performance standards, as well as other FDA regulations.

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