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..