Risk of Recall Associated With Modifications to High-risk Medical Devices Approved Through US Food and Drug Administration Supplements

IMPORTANCE: High-risk medical devices approved by the US Food and Drug Administration (FDA) can undergo modifications to their original premarket approval (PMA) via 1 of 5 types of supplements. Only panel track supplements (approximately 1%) require clinical data for approval. The association betwee...

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Detalles Bibliográficos
Autores principales: Dubin, Jonathan R., Enriquez, Jonathan R., Cheng, An-Lin, Campbell, Hunter, Cil, Akin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2023
Materias:
Original Investigation
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10099049/
https://www.ncbi.nlm.nih.gov/pubmed/37043202
http://dx.doi.org/10.1001/jamanetworkopen.2023.7699

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