Labeling
The U.S. Federal Food, Drug and Cosmetic Act 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 articles.
Our labeling reviews include each element of your product’s labeling including inner and out product labeling, operators manuals, promotional posters, tags, pamphlets, circulars, booklets, brochures, instructions, websites, social media, customer presentations and videos.
Realistic Quality Solutions will review all aspects of your products labeling and report and determine your device classifications and applicable labeling requirements.
For devices exempt from pre-market requirements, Realistic Quality Solutions cross references 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.
We’ll then prepare a detailed report outlining necessary changes to each element of your labeling and include print-ready files which incorporate the recommended changes.
