I
119THCONGRESS
1
STSESSION 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
JANUARY3, 2025
Mr. B
IGGSof 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 Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Medical Innovation Ac-4
celeration Act of 2025’’. 5
SEC. 2. EXEMPTING NON-INVASIVE DIAGNOSTIC DEVICES 6
FROM REGULATION AS DEVICES. 7
Section 201(h) of the Federal Food, Drug, and Cos-8
metic Act (21 U.S.C. 321(h)) is amended— 9
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•HR 88 IH
(1) by striking ‘‘section 520(o)’’ and inserting 1
the following: ‘‘section 520(o) or any non-invasive di-2
agnostic device’’; and 3
(2) by adding at the end the following: ‘‘For 4
purposes of the preceding sentence, the term ‘non- 5
invasive’ means, with respect to a diagnostic device, 6
that the device does not penetrate the skin or any 7
other membrane of the body, is not inserted or im-8
planted into the body, causes no more than ephem-9
eral compression or temperature changes to in situ 10
bodily tissues, and does not subject bodily tissues to 11
ionizing radiation.’’. 12
Æ
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