Evaluating regulatory oversight through major in vitro diagnostic recalls: a retrospective study of FDA data...

Area of Science:

• Medical Device Regulation
• In Vitro Diagnostics
• Public Health

Background:

• In vitro diagnostic (IVD) devices are crucial for accurate disease diagnosis and management.
• Diagnostic errors can lead to delayed or incorrect treatments, negatively impacting public health.

Purpose of the Study:

• To systematically analyze trends in Class I IVD recalls from the FDA database (2015-2024).
• To identify common reasons for recalls, affected IVD classes, and the impact of premarket notification (510(k)) exemption status.

Main Methods:

• Systematic analysis of the U.S. FDA recall database from 2015 to 2024.
• Focus on Class I IVD recalls, excluding Class II and III recalls.
• Evaluation of recall reasons, manufacturers, and 510(k) exemption status.

Main Results:

• A total of 100 Class I IVD recalls were reported between 2015 and 2024.
• Recalls primarily affected Approval-Class I (31) and Class II (69) IVDs.
• Deficiencies in process control were a major cause, particularly in Approval-Class I IVDs (12 of 31).
• A significant portion (23 of 31) of Approval-Class I IVDs were 510(k)-exempt.

Conclusions:

• Enhancing process control, device design, and manufacturing is vital to minimize Class I IVD recalls.
• Strengthening regulatory approaches with harmonized quality standards and AI-driven post-market surveillance can improve early detection of safety issues.
• These improvements are essential for safeguarding patient safety and advancing public health.