US and European postmarket clinical data requirements.
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.
Donawa
Maria
M
Donawa Consulting, Rome, Italy. medonawa@donawa.com
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