; and (B) review information and data provided to the Secretary by the sponsor of a contrast agent in an application submitted under section 505, so long as the sponsor of such contrast agent has provided to the sponsor of the applicable medical imaging device that is the subject of such review a right of reference or use. (3) An application submitted under section 515 or a notification submitted under section 510(k) with respect to an applicable medical imaging device shall be subject to the requirements of such respective section, and shall not be subject to subsection (d) or (e) of section 505 (including the substantial evidence standard specified in such subsections). (4) An application submitted under section 515 or a notification submitted under section 510(k) with respect to an applicable medical imaging device intended for use in conjunction with a contrast agent to which clause (ii) or (iii) of section 505(c)(3)(E) applies shall refer to such contrast agent by trade or brand name, rather than to a class of drugs. (5) For purposes of this subsection and section 505(y)— (A) the term applicable medical imaging device means a device intended to be used in conjunction with a contrast agent (or class of contrast agents) for a use that is not described in the indications and usage section of the approved labeling of such contrast agent (or the approved labeling of any contrast agent in the same class as such contrast agent); and (B) the term contrast agent means a drug that— (i) is a radioactive drug (as defined in section 310.3(n) of title 21, Code of Federal Regulations); or (ii) (I) is approved under section 505; (II) is intended for use in conjunction with a diagnostic imaging device