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Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017
IMPORTANCE: The US Food and Drug Administration (FDA) uses 510(k) clearance and premarket approval (PMA) pathways to ensure device safety before marketing. Premarket approval evaluates high-risk medical devices and requires clinical trials, whereas 510(k) clearance evaluates moderate-risk devices an...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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American Medical Association
2021
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8103223/ https://www.ncbi.nlm.nih.gov/pubmed/33956132 http://dx.doi.org/10.1001/jamanetworkopen.2021.7274 |