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Transparency and Dermatologic Device Approval by the US Food and Drug Administration

IMPORTANCE: The US Food and Drug Administration approves Class III medical devices via the premarket approval pathway, often requiring clinical data on safety and efficacy. Manufacturers can submit incremental device changes via supplemental applications, which are not subjected to such vetting meas...

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Detalhes bibliográficos
Publicado no:JAMA Dermatol
Main Authors: Ezaldein, Harib H., Scott, Jeffrey F., Yin, Emily S., Ventura, Alessandra, DeRuyter, Nicholaas P., Leffell, David J.
Formato: Artigo
Idioma:Inglês
Publicado em: American Medical Association 2018
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5885836/
https://ncbi.nlm.nih.gov/pubmed/29365020
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamadermatol.2017.5757
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