Section 1 Short title
This Act may be cited as the “Medical Innovation Acceleration Act of 2023”.
Medical Innovation Acceleration Act of 2023
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.
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—
by striking “section 520(o)” and inserting the following: “section 520(o) or any non-invasive diagnostic device”; and
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.”.