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...
Main Authors: | , , |
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Format: | Article |
Language: | English |
Published: |
Elsevier
2023-03-01
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Series: | Surgery in Practice and Science |
Subjects: | |
Online Access: | http://www.sciencedirect.com/science/article/pii/S2666262023000049 |