title: FDA: the regulatory process.
authors.affiliation: Mount Sinai Hospital, Toronto, Ontario, Canada.
authors.forename: A S
authors.initials: AS
authors.lastname: Slutsky
mesh_terms: D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000592:standards; D007221:Industry; D010344:Patient Advocacy; D012107:Research Design; D012121:Respiration, Artificial / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*; D012122:Ventilators, Mechanical / Q000592:standards*