Evaluating regulatory oversight through major in vitro diagnostic recalls: a retrospective study of FDA data (2015–2024)

BACKGROUND: In vitro diagnostic (IVD) devices play pivotal role in disease management by enabling an accurate and timely diagnosis. Diagnostic inaccuracies can harm public health by delaying or misguiding treatment. METHOD: 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. RESULT: = 69) IVDs. Among the Approval-Class I IVDs (31), 12 were attributed to deficiencies in process control. In Approval-Class II, nine recalls were attributed to process control issues, non-conforming materials, device design, labeling change control, and other flaws. Notably, 23 of 31 Approval-Class I IVDs were 510(k)-exempt. CONCLUSION: Improving process control, device design, and manufacturing is essential to reducing Class I IVD recalls. Strengthening regulatory strategies through harmonized quality standards and AI-based post-market surveillance can help detect safety issues early, enhancing patient safety and public health outcomes.