Medical Device Recall Improvement Act of 2025
Summary
The Medical Device Recall Improvement Act of 2025 aims to enhance the efficiency and accessibility of medical device recall notifications. It mandates the creation of an electronic format for these notifications, ensuring that manufacturers and importers submit recall information electronically to the Secretary of Health and Human Services. This act also requires the Secretary to maintain a publicly accessible electronic database of device recall notifications.
Expected Effects
The Act will lead to faster dissemination of recall information to healthcare professionals, device user facilities, and patients. It also mandates that patients who have been treated with recalled devices receive notice, especially in cases involving implanted, life-sustaining, or pediatric devices. This will improve patient safety and awareness regarding potentially harmful medical devices.
Potential Benefits
- Improved speed and efficiency of recall notifications through electronic submission.
- Enhanced accessibility of recall information for healthcare providers and patients via a public database.
- Direct notification to patients affected by device recalls, particularly for high-risk devices.
- Standardized data elements for recall notifications, ensuring comprehensive information.
- Increased transparency and accountability in the medical device recall process.
Potential Disadvantages
- Potential costs for manufacturers and importers to adapt to the new electronic notification system.
- Possible delays in the initial review process by the Secretary.
- The need for additional resources and personnel to maintain the electronic database.
- Risk of technical glitches or cybersecurity breaches affecting the database.
- Potential for increased administrative burden on healthcare facilities to notify patients.
Constitutional Alignment
The Act aligns with the Constitution's goal to "promote the general Welfare" by improving public health and safety through better regulation of medical devices. Congress's authority to regulate interstate commerce, as implied in Article I, Section 8, supports the regulation of medical device recalls. The Act does not appear to infringe on any specific constitutional rights or freedoms.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).