Medical Innovation Acceleration Act of 2023

I 118TH CONGRESS 1ST SESSION H. R. 71 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 9, 2023 Mr. BIGGS 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 2023’’. 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 VerDate Sep 11 2014 21:38 Jan 13, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H71.IH H71 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •HR 71 IH (1) by striking ‘‘section 520(o)’’ and inserting 1 the following: ‘‘section 520(o) or any non-invasive di- 2 agnostic device’’; and 3 (2) by adding at the end the following: ‘‘For 4 purposes of the preceding sentence, the term ‘non- 5 invasive’ means, with respect to a diagnostic device, 6 that the device does not penetrate the skin or any 7 other membrane of the body, is not inserted or im- 8 planted into the body, causes no more than ephem- 9 eral compression or temperature changes to in situ 10 bodily tissues, and does not subject bodily tissues to 11 ionizing radiation.’’. 12 Æ VerDate Sep 11 2014 21:38 Jan 13, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6301 E:\BILLS\H71.IH H71 pbinns on DSKJLVW7X2PROD with $$_JOB