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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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| Pubblicato in: | JAMA Dermatol |
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| Autori principali: | , , , , , |
| Natura: | Artigo |
| Lingua: | Inglês |
| Pubblicazione: |
American Medical Association
2018
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| Soggetti: | |
| 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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