title: The FDA's policy on the regulation of computerized medical devices.
authors.affiliation: Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD 20857.
authors.forename: C S
authors.initials: CS
authors.lastname: Furfine
mesh_terms: D004864:Equipment and Supplies; D007883:Legislation, Medical; D012984:Software; D014481:United States; D014486:United States Food and Drug Administration