new use
(3) Definitions For purposes of this subsection— (A) the term “new use” means a use of a contrast agent that is described in the approved labeling of an applicable medical imaging device described in section 360j(p) of this title , but that is not described in the approved labeling of the contrast agent; and (B) the terms “applicable medical imaging device” and “contrast agent” have the meanings given such terms in section 360j(p) of this title .