Abbott’s FreeStyle Libre 3 Correction: Critical Lessons for CGM Manufacturers on Post-Market Surveillance

What Happened: Abbott’s Proactive Device Correction

On November 24, 2025, Abbott voluntarily initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring (CGM) sensors in the United States. The correction was triggered by internal testing that revealed some sensors may provide incorrect low glucose readings, potentially putting patients at risk of missing critical hypoglycemic episodes.

This action represents a Class II device correction under FDA guidelines, demonstrating Abbott’s commitment to patient safety while highlighting the critical importance of robust post-market surveillance systems for all medical device manufacturers.

Why This Matters for Medical Device Manufacturers

Abbott’s swift response to potential accuracy issues offers several important compliance lessons for the broader medical device industry:

Post-Market Surveillance Excellence

Abbott’s internal testing that identified the issue exemplifies the gold standard for post-market surveillance. Under FDA’s Quality System Regulation (21 CFR Part 820) and ISO 13485:2016, manufacturers must maintain ongoing monitoring systems to detect potential device performance issues after market release.

Risk Management in Action

The potential for incorrect low glucose readings poses significant clinical risks, as patients may not receive appropriate warnings about dangerous hypoglycemic episodes. This scenario perfectly illustrates why manufacturers must conduct thorough risk analyses per ISO 14971 and maintain robust risk management files throughout the product lifecycle.

Voluntary vs. Mandatory Corrections

Abbott’s proactive approach likely helped avoid a mandatory FDA recall. Voluntary corrections often result in better regulatory relationships and demonstrate strong quality management systems to regulators.

Key Compliance Actions for Manufacturers

1. Strengthen Internal Testing Protocols

• Implement continuous performance monitoring for critical device functions
• Establish statistical process control methods to detect performance drift
• Document all testing protocols and results per FDA’s Design Controls requirements

2. Enhance Risk Management Systems

• Regularly update risk management files based on post-market data
• Establish clear risk acceptability criteria for device performance variations
• Implement risk-based corrective and preventive action (CAPA) procedures

3. Optimize Post-Market Surveillance

• Develop comprehensive post-market surveillance plans per ISO 13485 Section 8.2.1
• Establish clear triggers for initiating device corrections
• Train staff on MDR reporting requirements and timelines

Regulatory Framework and Reporting Requirements

Under 21 CFR Part 806, manufacturers must report device corrections to the FDA within 10 working days. The correction must include detailed information about affected devices, the nature of the problem, and corrective actions being taken.

For manufacturers with devices in international markets, similar reporting obligations exist under the EU MDR Article 87 and other global regulatory frameworks. Maintaining a centralized post-market surveillance system helps ensure compliance across multiple jurisdictions.

Best Practices Moving Forward

Medical device manufacturers should view Abbott’s action as a model for proactive quality management:

• Invest in continuous monitoring: Implement real-time performance tracking systems for critical device functions
• Maintain regulatory readiness: Prepare correction and recall procedures before they’re needed
• Foster a quality culture: Encourage early identification and reporting of potential issues
• Engage with regulators: Maintain open communication channels with regulatory bodies

Conclusion

Abbott’s FreeStyle Libre 3 correction demonstrates the value of robust post-market surveillance and proactive quality management. For medical device manufacturers, this case study reinforces the critical importance of continuous monitoring, effective risk management, and prompt corrective action when potential safety issues arise.

By implementing comprehensive post-market surveillance systems and maintaining a culture of quality excellence, manufacturers can protect patients while building stronger relationships with regulatory authorities and healthcare providers.