title: FDA pilot programme in support of global harmonisation.
abstract: Imagine having one document that would demostrate the conformity of a medical device with regualtory requirements worldwide. Although it may be some time before this goal is reached, the United States Food and Drug Administration is launching a premarket review pilot programme in support of  global harmonisation. This article discusses the programme and why European manufacturers should consider participating.
authors.affiliation: Donawa & Associates Ltd., Via Fonte di Fauno 22, I-00153 Rome, Italy. donawa@srd.it
authors.forename: Maria E
authors.initials: ME
authors.lastname: Donawa
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D019544:Equipment Failure Analysis / Q000379:methods / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D006078:Government Programs / Q000331:legislation & jurisprudence / Q000458:organization & administration* / Q000592:standards; D019983:Guideline Adherence / Q000331:legislation & jurisprudence / Q000592:standards; D017408:Guidelines as Topic; D007391:International Cooperation / Q000331:legislation & jurisprudence*; D010865:Pilot Projects; D011358:Product Surveillance, Postmarketing / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*