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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...

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Detalles Bibliográficos
Autores principales:	Dubin, Jonathan R., Simon, Stephen D., Norrell, Kirsten, Perera, Jacob, Gowen, Jacob, Cil, Akin
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	American Medical Association 2021
Materias:	Original Investigation
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

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