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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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Bibliografiske detaljer
Udgivet i:JAMA Dermatol
Main Authors: Ezaldein, Harib H., Scott, Jeffrey F., Yin, Emily S., Ventura, Alessandra, DeRuyter, Nicholaas P., Leffell, David J.
Format: Artigo
Sprog:Inglês
Udgivet: American Medical Association 2018
Fag:
Online adgang: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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