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Review of approvals and recalls of US specific medical devices in general and plastic surgery

Background: Medical devices in the United States can be FDA approved either by the premarket notification (510(k)) or premarket approval process (PMA). Applications for PMA are more intensive than 510(k). This study aims to compare the recall rates of 510(k) and PMA General and Plastic Surgery (Surg...

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Gespeichert in:
Hauptverfasser: Aashka Shah, Michelle M. Olson, Joseph M. Maurice
Format: Artigo
Sprache:Inglês
Veröffentlicht: Elsevier 2023-03-01
Schriftenreihe:Surgery in Practice and Science
Schlagworte:
FDA device approval
FDA device recall
510(k) pathway
Premarket approval process
General surgery
Plastic surgery
Online-Zugang:http://www.sciencedirect.com/science/article/pii/S2666262023000049
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