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

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.

Detalles Bibliográficos
Autores principales: Hines, Jonas Zajac, Lurie, Peter, Yu, Eunice, Wolfe, Sidney
Formato: Texto
Lenguaje:English
Publicado: Public Library of Science 2010
Materias:
Policy Forum
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2903853/
https://www.ncbi.nlm.nih.gov/pubmed/20634922
http://dx.doi.org/10.1371/journal.pmed.1000280
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author Hines, Jonas Zajac
Lurie, Peter
Yu, Eunice
Wolfe, Sidney
author_facet Hines, Jonas Zajac
Lurie, Peter
Yu, Eunice
Wolfe, Sidney
author_sort Hines, Jonas Zajac
collection PubMed
description 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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publishDate 2010
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spelling pubmed-29038532010-07-15 Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review Hines, Jonas Zajac Lurie, Peter Yu, Eunice Wolfe, Sidney PLoS Med Policy Forum 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. Public Library of Science 2010-07-13 /pmc/articles/PMC2903853/ /pubmed/20634922 http://dx.doi.org/10.1371/journal.pmed.1000280 Text en Hines et al. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Policy Forum
Hines, Jonas Zajac
Lurie, Peter
Yu, Eunice
Wolfe, Sidney
Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review
title Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review
title_full Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review
title_fullStr Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review
title_full_unstemmed Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review
title_short Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review
title_sort left to their own devices: breakdowns in united states medical device premarket review
topic Policy Forum
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2903853/
https://www.ncbi.nlm.nih.gov/pubmed/20634922
http://dx.doi.org/10.1371/journal.pmed.1000280
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AT luriepeter lefttotheirowndevicesbreakdownsinunitedstatesmedicaldevicepremarketreview
AT yueunice lefttotheirowndevicesbreakdownsinunitedstatesmedicaldevicepremarketreview
AT wolfesidney lefttotheirowndevicesbreakdownsinunitedstatesmedicaldevicepremarketreview

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