title: FDA spells out new reporting requirements.
authors.forename: M
authors.initials: M
authors.lastname: Infante
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004282:Documentation; D009735:Nursing Homes; D011358:Product Surveillance, Postmarketing; D012308:Risk Management; D014481:United States; D014486:United States Food and Drug Administration