July 13, 2010Open Access

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

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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.

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Hines et al. (Tue,) studied this question.

synapsesocial.com/papers/6a0eb7a2c12540356222a23d https://doi.org/https://doi.org/10.1371/journal.pmed.1000280

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