title: The impact of FDA reform.
abstract: The changes introduced by the Medical Device User Fee and Modernisation Act should ensure a timely and effective review process. The impact of some of the reforms is discussed here.
authors.affiliation: AdvaMed, Washington, District of Columbia, USA. jtrunzo@advamed.org
authors.forename: Janet
authors.initials: J
authors.lastname: Trunzo
mesh_terms: D001709:Biotechnology / Q000295:instrumentation / Q000331:legislation & jurisprudence; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence; D004864:Equipment and Supplies; D018166:Health Care Reform / Q000331:legislation & jurisprudence* / Q000639:trends; D007880:Legislation, Drug; D011356:Product Labeling / Q000331:legislation & jurisprudence; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards; D011640:Public Policy; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration* / Q000639:trends*