Medical Device Recall Improvement Act of 2025: New Electronic Notification Requirements for Manufacturers

Breaking Down H.R. 6594: What Manufacturers Need to Know

On December 10, 2025, Representative Janice D. Schakowsky introduced H.R. 6594, the Medical Device Recall Improvement Act of 2025, marking a significant potential shift in how medical device recalls are communicated and managed. This legislation proposes to modernize the recall notification process through the establishment of an electronic system, potentially transforming how manufacturers, healthcare providers, and patients receive critical safety information.

Current Recall Notification Challenges

The existing medical device recall system, while functional, faces several limitations that this new legislation aims to address:

• Communication delays: Traditional notification methods can result in delayed information reaching end users
• Inconsistent messaging: Varying formats and channels can create confusion among healthcare providers
• Limited tracking capabilities: Current systems make it difficult to verify receipt and implementation of recall notices
• Patient notification gaps: Direct patient communication remains challenging in many recall scenarios

What the Electronic System Could Mean

While the full text of H.R. 6594 provides more comprehensive details, the proposed electronic notification system would likely include several key components that medical device manufacturers should prepare for:

Enhanced Notification Speed

An electronic system would enable real-time communication of recall information, potentially reducing the time between FDA recall classification and end-user notification from days to hours or minutes. This acceleration could significantly improve patient safety outcomes and reduce liability exposure for manufacturers.

Standardized Communication Protocols

Electronic systems typically incorporate standardized formats and messaging protocols, ensuring consistent information delivery across all stakeholders. Manufacturers would need to adapt their internal recall procedures to align with these new standards.

Improved Tracking and Compliance Verification

Digital systems offer enhanced tracking capabilities, allowing manufacturers and regulatory authorities to monitor recall implementation progress more effectively. This could lead to more stringent compliance requirements and increased accountability for recall execution.

Immediate Actions for Medical Device Manufacturers

While H.R. 6594 is still in the early legislative stages with one cosponsor, proactive manufacturers should begin preparing for potential changes:

1. Review Current Recall Procedures

Conduct a comprehensive assessment of existing recall notification processes, identifying areas where electronic integration could be implemented. Document current communication channels, response times, and effectiveness metrics.

2. Evaluate Technology Infrastructure

Assess your organization’s current IT capabilities and identify potential gaps in electronic communication systems. Consider whether existing quality management systems can integrate with proposed electronic notification requirements.

3. Engage with Industry Associations

Participate in industry discussions about the proposed legislation through organizations like AdvaMed or MDMA. These groups often provide valuable insights into regulatory developments and implementation timelines.

4. Monitor Legislative Progress

Track the bill’s progress through Congress, including committee assignments, hearings, and amendments. Understanding the legislative timeline will help inform preparation strategies and resource allocation.

Regulatory Context and Implications

This proposed legislation aligns with broader FDA modernization efforts, including the agency’s emphasis on digital transformation and improved post-market surveillance. The electronic notification system would complement existing recall authorities under Section 518 of the Federal Food, Drug, and Cosmetic Act while potentially enhancing enforcement capabilities.

Manufacturers should also consider how these changes might affect their ISO 13485 quality management systems, particularly regarding corrective and preventive action (CAPA) processes and post-market surveillance activities.

Looking Ahead: Preparation Strategies

The introduction of H.R. 6594 represents an opportunity for forward-thinking manufacturers to enhance their recall capabilities proactively. Consider developing pilot programs for electronic recall communication, establishing relationships with technology vendors specializing in regulatory compliance solutions, and training quality assurance teams on digital communication protocols.

As the medical device industry continues to evolve toward greater digitalization and real-time communication, manufacturers who prepare early for these changes will be better positioned to maintain compliance while protecting patient safety and their business reputation.

Stay informed about H.R. 6594’s progress and be prepared to adapt your recall procedures as this legislation moves through the regulatory process. The investment in preparation today could significantly reduce compliance costs and risks tomorrow.