H.R. 88
Medical Innovation Acceleration Act of 2025
In Plain Language
This bill removes FDA oversight from noninvasive diagnostic devices — tools that don't break the skin, aren't inserted into the body, and don't cause lasting tissue changes or radiation exposure. These devices would no longer need FDA approval before being used to diagnose medical conditions.
Official Congressional Research Service summary
Medical Innovation Acceleration Act of 2025This bill exempts noninvasive diagnostic devices from the regulatory authority of the Food and Drug Administration.The bill defines noninvasive diagnostic device 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.
Sponsor
Cosponsors
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Latest action
Referred to the House Committee on Energy and Commerce.
Jan 3, 2025
Official source
Action history
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