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MEDICAL DEVICES


PRODUCT ASSESMENT AND LABEL REVIEW

The U.S. FDA regulates medical device products intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease intended to affect the structure or any function of the body of humans or other animals. MEDERA Consulting provides Registration and Regulatory Compliance Assistance for U.S. and Non-U.S. Companies in the Medical Device Industry.

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.

MEDERA Consulting helps companies determine their devices likely classification and applicable labeling requirements. For devices exempt from premarket requirements, MEDERA 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. MEDERA's label review service provides:

  • A detailed report (typically 10-20 pages) that 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 90 days at no extra cost.

MEDERA can provide a Free Assessment of how these regulations apply to your particular product. Simply contact us to provide information about your products. To receive our free white paper on marketing a healthcare product in U.S., please click here.