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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.
| Autores principales: | , , , |
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| Formato: | Texto |
| Lenguaje: | English |
| Publicado: |
Public Library of Science
2010
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| 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 |