| 1 | 1 | | I |
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| 2 | 2 | | 119THCONGRESS |
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| 3 | 3 | | 1 |
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| 4 | 4 | | STSESSION H. R. 88 |
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| 5 | 5 | | To amend the Federal Food, Drug, and Cosmetic Act to exempt from |
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| 6 | 6 | | regulation as devices non-invasive diagnostic devices, and for other purposes. |
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| 7 | 7 | | IN THE HOUSE OF REPRESENTATIVES |
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| 8 | 8 | | JANUARY3, 2025 |
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| 9 | 9 | | Mr. B |
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| 10 | 10 | | IGGSof Arizona introduced the following bill; which was referred to the |
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| 11 | 11 | | Committee on Energy and Commerce |
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| 12 | 12 | | A BILL |
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| 13 | 13 | | To amend the Federal Food, Drug, and Cosmetic Act to |
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| 14 | 14 | | exempt from regulation as devices non-invasive diagnostic |
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| 15 | 15 | | devices, and for other purposes. |
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| 16 | 16 | | Be it enacted by the Senate and House of Representa-1 |
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| 17 | 17 | | tives of the United States of America in Congress assembled, 2 |
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| 18 | 18 | | SECTION 1. SHORT TITLE. 3 |
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| 19 | 19 | | This Act may be cited as the ‘‘Medical Innovation Ac-4 |
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| 20 | 20 | | celeration Act of 2025’’. 5 |
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| 21 | 21 | | SEC. 2. EXEMPTING NON-INVASIVE DIAGNOSTIC DEVICES 6 |
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| 22 | 22 | | FROM REGULATION AS DEVICES. 7 |
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| 23 | 23 | | Section 201(h) of the Federal Food, Drug, and Cos-8 |
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| 24 | 24 | | metic Act (21 U.S.C. 321(h)) is amended— 9 |
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| 25 | 25 | | VerDate Sep 11 2014 23:36 Jan 28, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H88.IH H88 |
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| 26 | 26 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 2 |
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| 27 | 27 | | •HR 88 IH |
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| 28 | 28 | | (1) by striking ‘‘section 520(o)’’ and inserting 1 |
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| 29 | 29 | | the following: ‘‘section 520(o) or any non-invasive di-2 |
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| 30 | 30 | | agnostic device’’; and 3 |
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| 31 | 31 | | (2) by adding at the end the following: ‘‘For 4 |
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| 32 | 32 | | purposes of the preceding sentence, the term ‘non- 5 |
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| 33 | 33 | | invasive’ means, with respect to a diagnostic device, 6 |
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| 34 | 34 | | that the device does not penetrate the skin or any 7 |
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| 35 | 35 | | other membrane of the body, is not inserted or im-8 |
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| 36 | 36 | | planted into the body, causes no more than ephem-9 |
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| 37 | 37 | | eral compression or temperature changes to in situ 10 |
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| 38 | 38 | | bodily tissues, and does not subject bodily tissues to 11 |
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| 39 | 39 | | ionizing radiation.’’. 12 |
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| 40 | 40 | | Æ |
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| 41 | 41 | | VerDate Sep 11 2014 23:36 Jan 28, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6301 E:\BILLS\H88.IH H88 |
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| 42 | 42 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB |
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