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 recall 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 containing information on device recalls.
Expected Effects
The act will likely lead to faster dissemination of recall information to healthcare professionals, device user facilities, and patients. This should improve patient safety by enabling quicker responses to device-related risks. The electronic database will provide greater transparency regarding medical device recalls.
Potential Benefits
- Improved patient safety through faster recall notifications.
- Increased transparency via a publicly accessible database.
- Enhanced efficiency in the recall process for manufacturers and regulators.
- Better-informed healthcare professionals and device user facilities.
- Standardized data elements for recall notifications, ensuring comprehensive information.
Potential Disadvantages
- Potential costs for manufacturers and importers to adapt to the new electronic notification system.
- Possible delays during the initial implementation phase as the system is established.
- Risk of data breaches or cybersecurity threats to the electronic database.
- The act authorizes appropriations, which may increase government spending.
- The act may create additional regulatory burdens for medical device companies.
Constitutional Alignment
The Act aligns with the Constitution's goal of promoting the general welfare (Preamble). Congress has the power to regulate interstate commerce, which includes the regulation of medical devices (Article I, Section 8, Clause 3). The Act does not appear to infringe on any specific constitutional rights or liberties.
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).