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

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...

Full description

Bibliographic Details
Main Authors: Aashka Shah, Michelle M. Olson, Joseph M. Maurice
Format: Article
Language:English
Published: Elsevier 2023-03-01
Series:Surgery in Practice and Science
Subjects:
FDA device approval
FDA device recall
510(k) pathway
Premarket approval process
General surgery
Plastic surgery
Online Access:http://www.sciencedirect.com/science/article/pii/S2666262023000049

Internet

http://www.sciencedirect.com/science/article/pii/S2666262023000049

Similar Items