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Health Law, Ethics, and Human RightsFree Preview

Regulation of Medical Devices in the United States and European Union

List of authors.
  • Daniel B. Kramer, M.D.,
  • Shuai Xu, M.Sc.,
  • and Aaron S. Kesselheim, M.D., J.D., M.P.H.

As compared with Europe, the United States generally requires more rigorous clinical testing of high-risk devices, which delays patients' access to new devices but may provide better assurance of device safety.

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Funding and Disclosures

Supported in part by a grant from the FDA Center for Devices and Radiological Health (to Drs. Kramer and Kesselheim), by a career development award from the Agency for Healthcare Research and Quality (K08HS18465-01, to Dr. Kesselheim), and by a Robert Wood Johnson Foundation Investigator Award in Health Policy Research (to Dr. Kesselheim).

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article (10.1056/NEJMhle1113918) was published on February 14, 2012, at NEJM.org.

We thank Alan Fraser, Graeme Tunbridge, and Stefan Menzl for their comments on an earlier draft of the manuscript.

Author Affiliations

From Harvard Medical School (D.B.K., S.X., A.S.K.), Cardiovascular Division, Beth Israel Deaconess Medical Center (D.B.K.), and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital (A.S.K.) — all in Boston.

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