title: Medical device postapproval safety monitoring: where does the United States stand?
authors.affiliation: From the Harvard Medical School, Boston, MA (P.V.R., D.B.K., A.S.K.); Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (P.V.R., D.B.K., A.S.K.); and the Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (D.B.K.).
authors.forename: Prashant V
authors.initials: PV
authors.lastname: Rajan
authors.affiliation: From the Harvard Medical School, Boston, MA (P.V.R., D.B.K., A.S.K.); Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (P.V.R., D.B.K., A.S.K.); and the Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (D.B.K.).
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Kramer
authors.affiliation: From the Harvard Medical School, Boston, MA (P.V.R., D.B.K., A.S.K.); Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (P.V.R., D.B.K., A.S.K.); and the Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (D.B.K.). akesselheim@partners.org.
authors.forename: Aaron S
authors.initials: AS
authors.lastname: Kesselheim
mesh_terms: D018795:Device Approval; D006801:Humans; D061214:Patient Safety; D011358:Product Surveillance, Postmarketing; D015397:Program Evaluation; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D014481:United States; D014486:United States Food and Drug Administration
keywords: United States Food and Drug Administration; equipment and supplies; product surveillance, postmarketing; registries