title: US and European postmarket clinical data requirements.
abstract: Under United States regulations, the Food and Drug Administration may require manufacturer to collect postmarket clinical data. In Europe, the role of postmarket clinical follow-up is described in a guidance document, but not specifically mentioned in the European Directives. This article discusses the two systems, which are similar, but also different in important aspects.
authors.affiliation: Donawa Consulting, Rome, Italy. medonawa@donawa.com
authors.forename: Maria
authors.initials: M
authors.lastname: Donawa
mesh_terms: D003257:Consumer Product Safety / Q000331:legislation & jurisprudence* / Q000592:standards*; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D038622:Internationality; D019221:Mandatory Reporting; D011356:Product Labeling / Q000331:legislation & jurisprudence / Q000592:standards; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000592:standards*; D014481:United States