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

Abstract

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 (Surgery) devices and to educate physicians about potential flaws in the approval process. Methods: This is a retrospective case study utilizing the public FDA Medical Device Recalls database. Inclusion criteria for this study includes devices approved by the Surgery Devices Panel via 510(k) or PMA in the United States between 11/2/2002- 11/9/2021. Results: Out of 8,985 devices, 81% of surgery devices were approved by 510(k) while 19% were approved by PMA. The recall rate for devices approved by PMA and 510(k) was 2.3% and 11.6% respectively (p < .01). 510(k) device recalls are 5.32 times more likely. The differences in severity of recall is also significant (p < .01). From 2002 to 2021, the percent of devices that were approved by 501(k) decreased (p < .01) but rate of recalls was consistent. Discussion and Conclusion: Surgical devices were overwhelmingly approved with 510(k) versus PMA. 510(k) applications are cheaper, faster, and less stringent. These factors may contribute to the disproportionate 510(k) approvals and the discrepancy in recall rates. Cardiology, Orthopedics, and Obstetrics and Gynecology have similar trends for devices that go through the 510(k) device approval pathway. Though the rate of 510(k) approvals in Surgery is decreasing, more must be done to ensure that the 510(k) process sufficiently minimizes potential patient risk.

Keywords

• FDA device approval
• FDA device recall
• 510(k) pathway
• Premarket approval process
• General surgery
• Plastic surgery