H.R.2372 - Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2025; DEVICE Act of 2025 (119th Congress)
Summary
H.R.2372, the DEVICE Act of 2025, aims to amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and ensure device cleanliness. The bill introduces new reporting requirements for device design changes and communications to foreign healthcare providers regarding device safety. It also addresses the reprocessing of reusable devices by including rapid assessment tests in the device definition and requiring validated instructions for use.
Expected Effects
The bill will likely increase the regulatory burden on medical device manufacturers. It mandates more transparency and oversight regarding device design, reprocessing, and safety communications. This could lead to safer medical devices and better healthcare outcomes.
Potential Benefits
- Enhanced Patient Safety: Increased reporting requirements can lead to quicker identification and resolution of device-related safety issues.
- Improved Device Cleanliness: The focus on reprocessing and rapid assessment tests can reduce the risk of infection from reusable devices.
- Greater Transparency: Reporting communications to foreign healthcare providers promotes global awareness of device safety concerns.
- Innovation in Cleaning Technologies: The Act encourages the development and use of rapid assessment tests for reprocessing.
- Better Information for Healthcare Providers: Validated instructions for use of rapid assessment tests will help ensure proper device reprocessing.
Most Benefited Areas:
Potential Disadvantages
- Increased Costs for Manufacturers: The new reporting requirements and validation processes may increase costs for medical device manufacturers, potentially leading to higher device prices.
- Regulatory Burden: The added regulations could stifle innovation and delay the introduction of new medical devices to the market.
- Potential for Over-Reporting: Manufacturers may over-report to avoid penalties, leading to information overload for the FDA.
- Enforcement Challenges: Ensuring compliance with the new reporting requirements may strain FDA resources.
- Competitive Disadvantage: US manufacturers may face a competitive disadvantage compared to foreign manufacturers who are not subject to the same regulations.
Constitutional Alignment
The bill appears to align with the Commerce Clause (Article I, Section 8, Clause 3) of the U.S. Constitution, as it regulates medical devices that are marketed in interstate commerce. The reporting requirements and device definition amendments fall under Congress's power to regulate interstate commerce to ensure public safety and health. There is no obvious conflict with any specific constitutional provision.
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).