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HomeU.S. FDA Radiation-Emitting Electronic Device Regulations › U.S. FDA Radiation-Emitting Electronic Device Labeling Requirements

U.S. FDA Radiation-Emitting Electronic Device Labeling Requirements


U.S. FDA Radiation-Emitting Electronic Device Labeling Regulations Can Be Complicated

Registrar Corp's team of Regulatory Advisors can help determine how U.S. FDA Radiation-Emitting Electronic Device product and labeling regulations may apply to your particular electronic product. Simply click below to receive information about Radiation-Emitting Electtronic Device labeling requirements.

Learn how U.S. FDA labeling regulations apply to your Radiation-Emitting Electronic Device >>

The U.S. Federal Food, Drug and Cosmetic Act (FFDCA) defines Radiation-Emitting Electronic Device "labeling" as all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. The term 'accompanying' is interpreted liberally to mean more than physical association with the food product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instructions, websites, etc.

Registrar Corp reviews Radiation-Emitting Electronic Device product labeling and placement to ensure compliance with U.S. FDA's extensive Radiation-Emitting Electronic Device performance standards, placement standards, and labeling requirements by cross referencing your Radiation-Emitting Electronic Device against thousands of pages within the Code of Federal Regulations as well as the Federal Register, Guidance Documents, Labeling Guides, and Warning Letters issued by U.S. FDA. Registrar Corp's Radiation-Emitting Electronic Device label review service provides:

  • A detailed report (typically 20-30 pages) prepared by our team of Regulatory Specialists who scrutinize every element of your Radiation-Emitting Electronic Device labeling,
  • A print-ready graphic file of your revised Radiation-Emitting Electronic Device label which incorporates our recommended changes,
  • Explanation and guidance regarding requirements for your specific Radiation-Emitting Electronic Device, and
  • A generous revision policy providing additional reports for your revised Radiation-Emitting Electronic Device label within 90 days at no extra cost.
Radiation-Emitting Electronic Device Label Example of Before and After Registrar Corp Labeling Review
Having your Radiation-Emitting Electronic Device labeling reviewed by Registrar Corp can prevent costly errors. To learn how this service would be beneficial for your particular Radiation-Emitting Electronic Device, simply click on the link below:

Learn how U.S. FDA labeling regulations apply to your Radiation-Emitting Electronic Device >>






 
U.S. FDA Regulations:

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



Fees:

Radiation-Emitting Device Electronic Product Review:
US$ 1495/product

Discounts are available for multiple products.
















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.


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