What This Bill Does · Plain English
Summary · Congress.gov
Medical Innovation Acceleration Act of 2025 This 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.
Action Timeline
2025-01-03
Referred to the House Committee on Energy and Commerce.
2025-01-03
Introduced in House
2025-01-03
Introduced in House
Frequently Asked Questions
Did HR.88 pass?
HR.88 is still alive. Current stage: COMMITTEE. Pass likelihood: 58%.
What does HR.88 do?
Medical Innovation Acceleration Act of 2025 This 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.
Who sponsored HR.88?
HR.88 was sponsored by Andy Biggs (R-Arizona).
Full Bill Text
119 HR 88 IH: Medical Innovation Acceleration Act of 2025 U.S. House of Representatives 2025-01-03 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. I 119th CONGRESS 1st Session H. R. 88 IN THE HOUSE OF REPRESENTATIVES January 3, 2025 Mr. Biggs of Arizona introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to exempt from regulation as devices non-invasive diagnostic devices, and for other purposes. 1. Short title This Act may be cited as the Medical Innovation Acceleration Act of 2025 . 2. Exempting non-invasive diagnostic devices from regulation as devices Section 201(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(h) ) is amended— (1) by striking section 520(o) and inserting the following: section 520(o) or any non-invasive diagnostic device ; and (2) by adding at the end the following: For purposes of the preceding sentence, the term non-invasive means, with respect to a diagnostic device, that the device 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. .
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