title: A pivotal medical-device case.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Sonder
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence*; D016365:Liability, Legal; D035521:Supreme Court Decisions; D014481:United States; D014486:United States Food and Drug Administration