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Home › U.S. FDA Radiation-Emitting Electronic Device Regulations

U.S. FDA Radiation-Emitting Electronic Device Regulations

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.


U.S. FDA Radiation-Emitting Electronic Device Requirements   Device Examples
Radiation-Emitting Device Certificate of Reporting
For assistance with U.S. FDA Radiation-Emitting Electronic Device regulations, simply click the Radiation-Emitting Electronic Device Establishment Certificate of Reporting shown on the left.
   
Radiation-Emitting Electronic Device Product and Labeling Review
Radiation-Emitting Product Review
Registrar Corp helps companies determine whether their products may be considered a Radiation-Emitting Electronic Device by the U.S. FDA. For products that are likely considered a Radiation-Emitting Electronic Device, Registrar Corp provides guidance regarding applicable U.S. FDA labeling requirements and performance standards, as well as other U.S. FDA regulations. To learn how U.S. FDA Radiation-Emitting Electronic Device regulations may apply to your products, simply click the Notice of FDA Action shown on the left.




 
U.S. FDA Regulations:

U.S. FDA Radiation-Emitting Electronic Device Reporting:
21 C.F.R. Part 1002 et seq.

U.S. FDA Radiation-Emitting Electronic Device Performance Standards: 21 C.F.R. Part 1010 et seq.




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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.