Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review
Open Access
- 13 July 2010
- journal article
- review article
- Published by Public Library of Science (PLoS) in PLoS Medicine
- Vol. 7 (7) , e1000280
- https://doi.org/10.1371/journal.pmed.1000280
Abstract
Using 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.Keywords
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