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
Descripción
Sumario: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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