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119-hr-88119th CongressWALLET

Medical Innovation Acceleration Act of 2025

Sponsored By: Representative Biggs, Andy [R-AZ-5]

Introduced

Summary

Exempts certain noninvasive diagnostic devices from FDA regulation. This bill would amend the Federal Food, Drug, and Cosmetic Act to exclude from device regulation any diagnostic product that fits a narrow "non-invasive" definition. That definition requires the device not penetrate the skin or other body membranes, not be inserted or implanted, cause no more than brief compression or temperature changes to bodily tissues, and not expose tissues to ionizing radiation.

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Bill Overview

Analyzed Economic Effects

1 provisions identified: 0 benefits, 0 costs, 1 mixed.

Fewer FDA rules for non-invasive tests

If enacted, some diagnostic devices would be exempt from many FDA device rules. To qualify, the test must not break the skin or any body membrane. It must not be inserted or implanted. It may only cause brief pressure or small temperature changes in tissues. It cannot expose tissues to ionizing radiation. This could get some tests to market faster and lower costs. But it could also reduce safety checks for patients.

Sponsors & CoSponsors

Sponsor

Biggs, Andy [R-AZ-5]

AZ • R

Cosponsors

There are no cosponsors for this bill.

Roll Call Votes

No roll call votes available for this bill.

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