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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Bibliographic Details
Published in:JAMA Netw Open
Main Authors: Dubin, Jonathan R., Simon, Stephen D., Norrell, Kirsten, Perera, Jacob, Gowen, Jacob, Cil, Akin
Format: Artigo
Language:Inglês
Published: American Medical Association 2021
Subjects:
Original Investigation
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC8103223/
https://ncbi.nlm.nih.gov/pubmed/33956132
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamanetworkopen.2021.7274
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