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Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019

This cross-sectional study characterizes the premarket clinical evidence supporting clearance of moderate-risk novel therapeutic medical devices by the US Food and Drug Administration.

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Detalhes bibliográficos
Publicado no:JAMA Intern Med
Main Authors: Johnston, James L., Dhruva, Sanket S., Ross, Joseph S., Rathi, Vinay K.
Formato: Artigo
Idioma:Inglês
Publicado em: American Medical Association 2020
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7551221/
https://ncbi.nlm.nih.gov/pubmed/33044513
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamainternmed.2020.3214
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