title: FDA medical device regulation and informed consent.
authors.affiliation: Department of Radiology, Massachusetts General Hospital, Boston 02114, USA.
authors.forename: J J
authors.initials: JJ
authors.lastname: Smith
authors.forename: M E
authors.initials: ME
authors.lastname: Jensen
authors.forename: J E
authors.initials: JE
authors.lastname: Dion
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent; D014481:United States; D014486:United States Food and Drug Administration