Medical device postapproval safety monitoring: where does the United States stand?

Circ Cardiovasc Qual Outcomes. 2015 Jan;8(1):124-31. doi: 10.1161/CIRCOUTCOMES.114.001460. Epub 2015 Jan 6.

¹ 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.).
² 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.

No abstract available

Keywords: United States Food and Drug Administration; equipment and supplies; product surveillance, postmarketing; registries.

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