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Medical Innovation Acceleration Act of 2025
To amend the Federal Food, Drug, and Cosmetic Act to exempt from regulation as devices non-invasive diagnostic devices, and for other purposes.
Summary
This bill exempts non-invasive diagnostic devices from regulation as medical devices under the Federal Food, Drug, and Cosmetic Act. Non-invasive diagnostic devices are defined as those that do not penetrate the skin or other body membranes, are not inserted or implanted into the body, cause only temporary compression or temperature changes to bodily tissues, and do not expose tissues to ionizing radiation. The exemption would allow manufacturers of these devices to avoid FDA device regulation requirements.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
- Rep. Biggs, Andy [R-AZ-5] (R-AZ)
Money behind the sponsor
Top reported contributors to Andy Biggs’s campaign committee (2024 cycle) — who funds the bill’s sponsor, not a claim about this bill. Data from FEC.
- SAULSBURY INDUSTRIES $9,900
- 21ST CENTURY HEALTHCARE $7,500
- ULINE $6,600
- TW LEWIS COMPANY $6,600
- LEE BENSON $6,600
Organizations whose employees gave the most — itemized individual contributions grouped by the donor’s reported employer (FEC Schedule A). Full finance for Andy Biggs → · Outside spending →
Actions (2)
- Jan 3, 2025 Referred to the House Committee on Energy and Commerce. · house
- Jan 3, 2025 Introduced in House
Similar bills (6)
Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.
Full text
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.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the “Medical Innovation Acceleration Act of 2025”.
SEC. 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.”. <all>
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