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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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Dettagli Bibliografici
Pubblicato in:JAMA Dermatol
Autori principali: Ezaldein, Harib H., Scott, Jeffrey F., Yin, Emily S., Ventura, Alessandra, DeRuyter, Nicholaas P., Leffell, David J.
Natura: Artigo
Lingua:Inglês
Pubblicazione: American Medical Association 2018
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Accesso online: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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