Bill Details
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This bill would change federal food and drug law so that certain non-invasive diagnostic tools would no longer be treated as medical devices under that law. In simple terms, it aims to make it easier for some low-risk diagnostic technologies to reach the market by reducing FDA device regulation. The bill says a diagnostic device is “non-invasive” if it does not break the skin or enter the body, is not implanted, does not cause more than brief compression or temperature changes in body tissue, and does not use ionizing radiation.
- It amends the legal definition of a medical device in the Federal Food, Drug, and Cosmetic Act.
- The change would carve out non-invasive diagnostic devices from that device category, which could mean less federal regulation for those products.
- The bill gives a specific definition of “non-invasive” to limit the exemption to devices that stay outside the body and do not use harmful radiation.
Official Summaries
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.
Current Full Text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 88 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 88
To amend the Federal Food, Drug, and Cosmetic Act to exempt from
regulation as devices non-invasive diagnostic devices, and for other
purposes.
_______________________________________________________________________
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.''.
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