• PLoS medicine · Jul 2010

    Review Historical Article

    Left to their own devices: breakdowns in United States medical device premarket review.

    • Jonas Zajac Hines, Peter Lurie, Eunice Yu, and Sidney Wolfe.
    • Health Research Group at Public Citizen, Washington, DC, United States of America. jonas.hines@ucsf.edu
    • PLoS Med. 2010 Jul 13; 7 (7): e1000280e1000280.

    AbstractUsing examples from recent FDA regulatory proceedings, Jonas Hines and colleagues critique the medical device premarket review and identify eight weaknesses in the process that should be remedied.

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