Advertisement
Research Article

How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review

  • Daniel B. Kramer mail,

    dkramer@bidmc.harvard.edu

    Affiliations: Harvard Medical School, Boston, Massachusetts, United States of America, Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America

    X
  • Shuai Xu,

    Affiliation: Harvard Medical School, Boston, Massachusetts, United States of America

    X
  • Aaron S. Kesselheim

    Affiliations: Harvard Medical School, Boston, Massachusetts, United States of America, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, United States of America

    X
  • Published: July 31, 2012
  • DOI: 10.1371/journal.pmed.1001276

About the Authors

Daniel B. Kramer, Shuai Xu, Aaron S. Kesselheim
Harvard Medical School, Boston, Massachusetts, United States of America
Daniel B. Kramer
Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America
Aaron S. Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, United States of America

Corresponding Author

Email: dkramer@bidmc.harvard.edu

Competing Interests

DBK is a consultant to Circulatory Systems Advisory Panel of the Food and Drug Administration. SX reports being an inventor on three patent applications related to medical devices, but none of these devices are approved or under review or have applications pending to the FDA or any other regulatory agency. SX also reports being employed by Blue Box Health (until he started medical school in 2009), a closely held medical device company. He holds ex-employee stock options in this company (which has no device currently approved or under review or application pending before the FDA), but has no connection with the company or knowledge of its future plans. The authors declare that no other competing interests exist.

Author Contributions

Conceived and designed the experiments: DBK SX ASK. Performed the experiments: DBK SX. Analyzed the data: DBK SX. Contributed reagents/materials/analysis tools: DBK SX ASK. Wrote the first draft of the manuscript: DBK SX. Contributed to the writing of the manuscript: DBK SX ASK. ICMJE criteria for authorship read and met: DBK SX ASK. Agree with manuscript results and conclusions: DBK SX ASK.