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Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review

  • Jonas Zajac Hines mail,

    jonas.hines@ucsf.edu

    Affiliation: Health Research Group at Public Citizen, Washington, D.C., United States of America

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  • Peter Lurie,

    Affiliation: Health Research Group at Public Citizen, Washington, D.C., United States of America

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  • Eunice Yu,

    Affiliation: Health Research Group at Public Citizen, Washington, D.C., United States of America

    X
  • Sidney Wolfe

    Affiliation: Health Research Group at Public Citizen, Washington, D.C., United States of America

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  • Published: July 13, 2010
  • DOI: 10.1371/journal.pmed.1000280

About the Authors

Jonas Zajac Hines, Peter Lurie, Eunice Yu, Sidney Wolfe
Health Research Group at Public Citizen, Washington, D.C., United States of America

Corresponding Author

Email: jonas.hines@ucsf.edu

Competing Interests

PL is now with the U.S. Food and Drug Administration, where he is Senior Advisor in the Office of the Commissioner. He began at the FDA in December 2009; the manuscript was submitted before he began employment at the FDA. The opinions expressed here are his and do not represent the official position of the U.S. FDA or the U.S. government.

Author Contributions

ICMJE criteria for authorship read and met: JZH PL EY SW. Agree with the manuscript's results and conclusions: JZH PL EY SW. Designed the experiments/the study: JZH PL. Analyzed the data: JZH EY. Wrote the first draft of the paper: JZH. Contributed to the writing of the paper: JZH PL EY SW.