title: FDA user fee and Modernisation Act.
abstract: A new law authorises the Food and Drug Administration to collect fees on medical device premarket submissions. The law also introduces important medical device regulatory reforms. This article discusses this new law and comments on the impact that it could have on the medical device industry.
authors.affiliation: donawa@srd.it
authors.forename: Maria
authors.initials: M
authors.lastname: Donawa
mesh_terms: D001709:Biotechnology / Q000191:economics* / Q000295:instrumentation / Q000331:legislation & jurisprudence*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004209:Disposable Equipment / Q000191:economics* / Q000592:standards; D017743:Equipment Reuse / Q000191:economics / Q000331:legislation & jurisprudence; D004864:Equipment and Supplies / Q000592:standards; D005249:Fees and Charges / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration / Q000191:economics / Q000331:legislation & jurisprudence*