Evaluating regulatory oversight through major

Abstract

A systematic analysis of the publicly available U.S. FDA recall database (201-2024) was conducted to evaluate the trends in Class I IVD recalls, focusing on approved class, recall reasons, manufacturers, and premarket notification (510 k) exemption status. Class II and III recalls were excluded from this study. Between 2015 and 2024, a total of 100 Class I recall IVDs were reported. Over these 10 years, the major recalls were limited to Approval-Class I ( Improving process control, device desig