title: Riegel v. Medtronic, Inc.: revisiting pre-emption for medical devices.
abstract: The recent United States Supreme Court decision in Riegel v. Medtronic, Inc. affirmed the doctrine of pre-emption protection only for those medical devices reaching U.S. markets via the PMA (premarketing approval) process and preserved the previous Lohr v. Medtronic decision's lack of preemption protection for those medical devices marketed via the generally more abbreviated 510(k) clearance mechanism. This paper reviews the logic and faults of the Riegel decision and discusses the implications of the Riegel decision for pre-emption protection for other classes of FDA-approved medical products.
authors.affiliation: University of Houston Law Center, Health Law and Policy Institute, TX, USA.
authors.forename: Bruce
authors.initials: B
authors.lastname: Patsner
mesh_terms: D001688:Biological Products; D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D006801:Humans; D016365:Liability, Legal; D056687:Off-Label Use / Q000331:legislation & jurisprudence; D035521:Supreme Court Decisions; D014481:United States
chemical_list: D001688:Biological Products