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

Abstract

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 (Surgery) devices and to educate physicians about potential flaws in the approval process. This is a retrospective case study utilizing the public FDA Medical Device Recalls database. Inclusion criteria for this study