title: Point/counterpoint, legal perspective.
authors.affiliation: Covington & Burling, Washington, District of Columbia 20044-7566, USA.
authors.forename: E J
authors.initials: EJ
authors.lastname: Flannery
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D007883:Legislation, Medical; D016134:Organizational Policy; D014481:United States; D014486:United States Food and Drug Administration