; or (ii) (I) is approved under section 505; (II) is intended for use in conjunction with a diagnostic imaging device; and (III) achieves its intended use by enhancing the contrast between a target tissue, structure, or fluid and the surrounding tissues or structures within the body. . 3. Applications for approval of contrast agents intended for use with certain diagnostic medical imaging devices Section 505 of the Federal Food, Drug, and Cosmetic Act ( 42 U.S.C. 355 ) is amended by adding at the end the following: (y) Contrast agents intended for use with applicable medical imaging devices (1) The sponsor of a contrast agent for which an application has been approved under this section may submit a supplement to the application seeking approval for the use of the contrast agent for a new contrast indication. (2) In reviewing a supplement submitted under this subsection, the agency center charged with the premarket review of drugs may— (A) consult with the center charged with the premarket review of devices; and (B) review information and data submitted to the Secretary by the sponsor of an applicable medical imaging device pursuant to section 515 or 510(k), so long as the sponsor of such applicable medical imaging device has provided to the sponsor of the contrast agent a right of reference or use. (3) For purposes of this subsection— (A) the term new contrast indication means a use of a contrast agent that is described in the approved labeling of an applicable medical imaging device described in section 520(p), but that is not described in the indications and usage section of the approved labeling of the contrast agent; and (B) the term applicable medical imaging device and contrast agent have the meanings given such terms in section 520(p). .