H.R. 6594: Medical Device Recall Improvement Act Could Transform Recall Management for Manufacturers

New Congressional Legislation Takes Aim at Medical Device Recall Processes

Representative Janice D. Schakowsky has introduced H.R. 6594, the Medical Device Recall Improvement Act of 2025, marking a significant potential shift in how medical device recalls are managed and executed. This proposed legislation comes at a time when medical device manufacturers face increasing scrutiny over post-market surveillance and recall effectiveness.

What the Medical Device Recall Improvement Act Proposes

While specific details of H.R. 6594 are still emerging, the introduction of recall improvement legislation typically focuses on several key areas that directly impact medical device manufacturers:

• Enhanced FDA Authority: Potential expansion of FDA’s power to mandate recalls rather than relying on voluntary manufacturer cooperation
• Improved Communication Requirements: Stricter timelines and methods for notifying healthcare providers and patients about recalls
• Post-Market Surveillance Enhancements: More robust requirements for ongoing device monitoring and adverse event reporting
• Recall Effectiveness Metrics: Standardized measures to evaluate how successfully recalls remove dangerous devices from circulation

Why This Legislation Matters to Medical Device Manufacturers

The introduction of H.R. 6594 signals growing Congressional concern about medical device safety and recall effectiveness. Recent high-profile recalls, including those involving cardiac devices, surgical mesh, and diagnostic equipment, have highlighted gaps in the current recall system that this legislation likely aims to address.

For manufacturers, this proposed legislation could mean:

• Increased Compliance Costs: New requirements may necessitate additional quality management system investments
• Faster Response Times: Tighter deadlines for recall initiation and communication
• Enhanced Documentation: More detailed record-keeping requirements for post-market surveillance activities
• Greater Liability Exposure: Potential penalties for non-compliance with recall procedures

Current Recall Framework Under FDA Regulations

Under existing 21 CFR Part 806, medical device manufacturers must report corrections and removals to the FDA within 10 working days when the action is taken to reduce a risk to health or to remedy a violation that may present a risk to health. The current system relies heavily on voluntary manufacturer cooperation, with FDA having limited authority to mandate recalls except in specific circumstances.

The proposed legislation likely seeks to strengthen this framework by providing FDA with additional tools and authority to ensure recall effectiveness.

Immediate Actions for Medical Device Manufacturers

While H.R. 6594 moves through the legislative process, manufacturers should take proactive steps to strengthen their recall preparedness:

1. Review Current Recall Procedures

• Audit existing recall plans against FDA guidance documents
• Ensure compliance with ISO 13485 requirements for corrective and preventive actions
• Verify that recall communication templates meet current regulatory standards

2. Strengthen Post-Market Surveillance Systems

• Implement robust adverse event monitoring systems
• Enhance traceability systems to enable rapid device identification
• Develop clear escalation procedures for safety signal detection

3. Prepare for Enhanced Requirements

• Establish cross-functional recall teams with clear roles and responsibilities
• Create comprehensive recall communication strategies
• Develop metrics to measure recall effectiveness

Looking Ahead: Legislative Timeline and Industry Impact

As H.R. 6594 progresses through Congress, medical device manufacturers should monitor its development closely. The bill will likely undergo committee review, potential amendments, and industry stakeholder feedback before any final passage.

Industry associations such as AdvaMed and MDMA will undoubtedly provide input on the legislation’s provisions, potentially influencing its final form. Manufacturers should engage with these organizations and consider providing feedback during public comment periods.

The introduction of this legislation underscores the importance of proactive recall preparedness and robust quality management systems. Manufacturers who invest in comprehensive post-market surveillance and recall capabilities now will be better positioned to adapt to any new requirements that emerge from this legislative process.