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Medical Innovation Acceleration: Easing Rules for Diagnostic Devices

This new law aims to exempt certain non-invasive diagnostic devices from strict regulations. This means new medical technologies that do not penetrate the body can reach the market faster. As a result, citizens may gain earlier access to innovative disease diagnosis methods.
Key points
Diagnostic devices that do not penetrate the skin or body will no longer be subject to the same regulations as other medical devices.
The definition of "non-invasive" includes devices that do not cause permanent tissue changes or use ionizing radiation.
This change could accelerate the development and availability of new, safe tools for diagnosing diseases.
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Introduced
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Additional Information
Print number: 119_HR_88
Sponsor: Rep. Biggs, Andy [R-AZ-5]
Process start date: 2025-01-03