title: An important step forward in the global harmonisation of premarket review programmes.
abstract: The United States Food and Drug Administration (FDA) has announced its intention to launch an extraordinary new pilot programme that could have a significant effect on efforts to harmonise premarket review procedures worldwide. This article discusses the programme and the importance of submitting comments to FDA on this new initiative.
authors.affiliation: donawa@srd.it
authors.forename: M
authors.initials: M
authors.lastname: Donawa
mesh_terms: D000818:Animals; D001315:Australia; D002170:Canada; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D019544:Equipment Failure Analysis / Q000379:methods / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D006801:Humans; D010865:Pilot Projects; D014481:United States; D014486:United States Food and Drug Administration