title: Medical device reporting: the US final rule.
abstract: On 11 December 1995, the United States (US) Food and Drug Administration (FDA) published new medical device reporting (MDR) regulations for reports submitted by manufacturers and user facilities. The new regulations, which also revise the regulations for registration and listing, become effective on 11 April 1996. They also impose requirements on nonUS medical device manufacturers. This article discusses the new MDR requirements, including those related to nonUS medical device manufacturers.
authors.affiliation: Donawa and Associates Ltd., Rome, Italy.
authors.forename: M E
authors.initials: ME
authors.lastname: Donawa
mesh_terms: D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000592:standards*; D005161:Facility Regulation and Control; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012042:Registries; D014481:United States; D014486:United States Food and Drug Administration