Fees: Product, Label, and Graphic Design for Medical Devices
The fee for a Product, Labeling and Graphic Design for Medical Devices is US$ 1,495.1 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 10-20 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 90 days at no extra cost.
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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.
