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U.S. FDA Medical Device Labeling Requirements

U.S. FDA CITATION: 21 C.F.R. § 801 (2016)

U.S. FDA Medical Device Labeling Regulations Can Be Complicated

Registrar Corp’s team of Regulatory Advisors can provide a Free Assessment of how these regulations apply to
your particular product.  Simply click below to provide information about your products.

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The U.S. Federal Food, Drug and Cosmetic Act (FFDCA) defines “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 product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instructions, websites, etc.
Registrar Corp helps companies determine their devices likely classification and applicable labeling requirements. For devices exempt from premarket requirements, Registrar Corp cross references your labeling 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 label review service provides:

  • A detailed report (typically 20-40 pages) prepared by our team of Regulatory Specialists who scrutinize each element of your labeling (including inner packaging, outer packaging, website, etc.).
  • A print-ready graphic file of your revised label which incorporates our recommended changes.
  • A generous revision policy providing additional reports and revisions for the same label within 30 days at no extra cost.

Learn if these regulations apply to you >>