H.R.88 - Medical Innovation Acceleration Act of 2025 (119th Congress)
Summary
H.R.88, the Medical Innovation Acceleration Act of 2025, aims to amend the Federal Food, Drug, and Cosmetic Act. The core change involves exempting non-invasive diagnostic devices from being regulated as devices under the Act. The bill defines 'non-invasive' as devices that do not penetrate the skin or other bodily membranes, are not inserted or implanted, cause only ephemeral compression or temperature changes, and do not subject tissues to ionizing radiation.
Expected Effects
The likely effect of this bill is a reduction in regulatory burden for manufacturers of non-invasive diagnostic devices. This could lead to faster development and deployment of these technologies. It may also reduce the cost of these devices, potentially increasing access for patients.
Potential Benefits
- Faster Innovation: Reduced regulatory hurdles could accelerate the development and introduction of new non-invasive diagnostic tools.
- Lower Costs: Less regulation may translate to lower development and production costs, potentially reducing the price of these devices for consumers.
- Increased Access: More affordable and readily available diagnostic devices could improve access to healthcare, especially for those in underserved communities.
- Focus on High-Risk Devices: By exempting low-risk devices, the FDA can focus its resources on regulating higher-risk medical devices.
- Economic Growth: The medical device industry could see growth due to increased innovation and market access.
Most Benefited Areas:
Potential Disadvantages
- Potential for Reduced Safety Oversight: Exempting devices from regulation could lead to a decrease in safety monitoring and quality control.
- Risk of Inaccurate Results: Without proper regulation, there is a risk of less accurate or reliable diagnostic devices entering the market.
- Lack of Transparency: Reduced regulation could lead to less transparency regarding the performance and safety of these devices.
- Uneven Playing Field: Established manufacturers who adhere to strict regulations may be at a disadvantage compared to new entrants who are not subject to the same requirements.
- Difficulty in Recalling Defective Devices: Without regulatory oversight, it may be more challenging to track and recall defective or harmful devices.
Constitutional Alignment
The bill appears to align with the Constitution, particularly Article I, Section 8, which grants Congress the power to regulate commerce. This power extends to regulating the manufacture and sale of medical devices. The exemption of certain devices from regulation is a policy choice within the scope of Congress's authority. The bill does not appear to infringe on any individual rights or liberties protected by the Constitution or its amendments.
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).