Differing definitions of manufacturer.
Medical device manufacturers marketing in the United States (US) and Europe must comply with different labelling requirements concerning the indication of manufacturer on the label. These differences are increased if US labelling requirements are compared with the practice of own-brand labelling under the European medical device Directives. This article discusses the differing requirements.
Donawa
M E
ME
Donawa and Associates Ltd., Rome, Italy. donawa@srd.it
D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D016365:Liability, Legal; D011356:Product Labeling / Q000331:legislation & jurisprudence*; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence