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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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Détails bibliographiques
Publié dans:JAMA Dermatol
Auteurs principaux: Ezaldein, Harib H., Scott, Jeffrey F., Yin, Emily S., Ventura, Alessandra, DeRuyter, Nicholaas P., Leffell, David J.
Format: Artigo
Langue:Inglês
Publié: American Medical Association 2018
Sujets:
Accès en ligne: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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