Understanding US labelling requirements.
Medical device manufacturers should not assume that the information and symbols on labels for the European market are always suitable to meet United States (US) requirements. This article discusses US labelling requirements and how they differ from European requirements.
Donawa
Maria
M
Donawa Consulting, Rome, Italy. medonawa@donawa.com
D004282:Documentation / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D033161:Government Regulation; D019983:Guideline Adherence; D017408:Guidelines as Topic; D011356:Product Labeling / Q000331:legislation & jurisprudence* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*