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doi.org/10.1371/journal.pmed.1000280

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

..., Sidney Wolfe
9
PLOS Medicine15.80
Volume: 7, Issue: 7, Pages: e1000280 - e1000280
Published: Jul 13, 2010
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...
Paper Fields
Paper Details
Title
Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review
DOI
doi.org/10.1371/journal.pmed.1000280
Published Date
Jul 13, 2010
Journal
PLOS Medicine
Volume
7
Issue
7
Pages
e1000280 - e1000280
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