title: FDA software policy and regulation of medical device software.
authors.affiliation: Center for Devices and Radiological Health, Food and Drug Administration, USA.
authors.forename: E S
authors.initials: ES
authors.lastname: Crumpler
authors.forename: H
authors.initials: H
authors.lastname: Rudolph
mesh_terms: D004864:Equipment and Supplies / Q000592:standards; D006801:Humans; D007883:Legislation, Medical; D011640:Public Policy; D012984:Software / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration