New Congressional Legislation Aims to Strengthen Medical Device Recall Process: What Manufacturers Need to Know

Congressional Initiative Targets Medical Device Recall Reform

Representatives Jan Schakowsky and Senator Dick Durbin have introduced new federal legislation designed to improve the medical device recall process, signaling potential significant changes for how manufacturers manage post-market safety issues. This bipartisan initiative comes amid ongoing concerns about the effectiveness of current recall procedures and their impact on patient safety.

Current Recall Process Challenges

The existing medical device recall framework has faced criticism for several key issues that this legislation likely aims to address:

• Limited FDA Authority: Unlike drug recalls, the FDA cannot mandate medical device recalls except in rare circumstances, relying primarily on voluntary manufacturer cooperation
• Notification Delays: Inconsistent timelines for notifying healthcare providers and patients about recalled devices
• Incomplete Recall Effectiveness: Challenges in tracking recall completion rates and ensuring all affected devices are removed from circulation
• Post-Market Surveillance Gaps: Insufficient mechanisms for ongoing monitoring of device safety after market introduction

Implications for Medical Device Manufacturers

This legislative development represents a potentially transformative shift in recall responsibilities and regulatory oversight. Manufacturers should prepare for enhanced requirements that may include:

Strengthened Reporting Obligations

The legislation will likely expand mandatory reporting requirements under 21 CFR Part 803, potentially requiring faster notification timelines and more detailed safety data submission. Manufacturers may need to enhance their adverse event monitoring systems to meet stricter reporting standards.

Enhanced Post-Market Surveillance

Expect new requirements for robust post-market clinical follow-up (PMCF) programs, particularly for Class II and III devices. This aligns with international trends toward lifecycle-based regulatory approaches similar to EU MDR requirements.

Improved Recall Execution Standards

The legislation may establish specific performance metrics for recall effectiveness, requiring manufacturers to demonstrate successful device retrieval and corrective action implementation within defined timeframes.

Proactive Compliance Strategies

Medical device manufacturers should take immediate steps to prepare for potential regulatory changes:

1. Strengthen Quality Management Systems

Review and enhance your ISO 13485 quality management system to ensure robust post-market surveillance capabilities. Focus on improving complaint handling procedures under section 8.2.2 and management review processes.

2. Enhance Risk Management Processes

Update risk management files per ISO 14971 to include comprehensive post-market risk analysis procedures. Ensure your risk management process can rapidly identify and assess emerging safety signals.

3. Develop Comprehensive Recall Procedures

Create detailed recall procedures that exceed current FDA guidance, including:

• Clear decision-making criteria for initiating recalls
• Rapid notification protocols for all stakeholders
• Tracking systems for recall effectiveness monitoring
• Corrective and preventive action (CAPA) integration

4. Invest in Digital Infrastructure

Consider implementing advanced tracking technologies such as unique device identification (UDI) systems and digital supply chain management tools to enable rapid device identification and retrieval during recalls.

Monitoring Legislative Progress

Stay informed about this legislation’s development by monitoring FDA guidance updates and industry association communications. The final requirements may significantly impact manufacturing timelines, quality system procedures, and regulatory submission strategies.

Conclusion

While the specific details of the Schakowsky-Durbin legislation remain to be finalized, medical device manufacturers should proactively strengthen their recall preparedness and post-market surveillance capabilities. This legislative initiative reflects growing regulatory focus on device safety throughout the product lifecycle, making robust compliance infrastructure more critical than ever for maintaining market access and protecting patient safety.