House Bill
Andy Biggs
R - AZ
Cosponsors
0
Summary
This bill exempts noninvasive diagnostic devices from FDA regulation. It applies to devices that do not penetrate skin, are not inserted into the body, cause only temporary tissue effects, and do not use ionizing radiation.
Latest Action
Referred to the House Committee on Energy and Commerce.
Plain-English explanation of this bill
This bill exempts noninvasive diagnostic devices from FDA regulation. It applies to devices that do not penetrate skin, are not inserted into the body, cause only temporary tissue effects, and do not use ionizing radiation.
Last updated: 1/5/2026
Congressional Research Service summary
<p><strong>Medical Innovation Acceleration Act of 2025</strong></p><p>This bill exempts noninvasive diagnostic devices from the regulatory authority of the Food and Drug Administration.</p><p>The bill defines <em>noninvasive diagnostic device</em> as one that does not penetrate the skin or any other membrane of the body, is not inserted or implanted into the body, causes no more than ephemeral compression or temperature changes to in situ bodily tissues, and does not subject bodily tissues to ionizing radiation.</p>
Main provisions of the bill
Potential effects on citizens and communities
Medical device companies could bring noninvasive diagnostics to market faster. Patients could have earlier access to diagnostic technologies. Critics worry about reduced safety oversight for these devices.
No policy areas assigned yet.
Jurisdiction Level
federal
Congressional Session
119th Congress
Citation Reference
88, 119th Congress (2025). "Medical Innovation Acceleration Act of 2025". Source: Voter's Right Platform. https://votersright.org/bills/118-hr-88