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Easier Access for Non-Invasive Diagnostic Devices

This bill aims to exempt certain non-invasive diagnostic devices from regulation as medical devices. This means devices that do not penetrate the skin or body tissues will not require as stringent approvals, potentially speeding up their market availability and reducing costs. For citizens, this could mean quicker access to new, simpler medical diagnostic methods.
Key points
Diagnostic devices that do not enter the body (e.g., do not break the skin) will no longer be treated as medical devices subject to strict regulations.
This change may accelerate the market introduction of new, safe diagnostic methods, potentially lowering their prices and increasing patient access.
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Additional Information
Print number: 117_HR_6513
Sponsor: Rep. Biggs, Andy [R-AZ-5]
Process start date: 2022-01-28