title: FDA model for regulatory purposes.
authors.affiliation: Center for Devices and Radiological Health, Rockville, Maryland 20857.
authors.forename: M E
authors.initials: ME
authors.lastname: Stratmeyer
mesh_terms: D004869:Equipment Safety; D006801:Humans; D008954:Models, Biological; D014463:Ultrasonography / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration