Sec. 802. Applications for approval of contrast agents intended for use with certain diagnostic medical imaging devices
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Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) is amended by adding at the end the following: 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 indication and conditions of use following the authorization of a premarket submission for an applicable medical imaging device for that use with the contrast agent pursuant to section 520(q)(1).
In reviewing a supplement submitted under this subsection, the agency center charged with the premarket review of drugs may— consult with the center charged with the premarket review of devices; and review information and data submitted to the Secretary by the sponsor of an applicable medical imaging device pursuant to section 515, 510(k), or 513(f)(2) so long as the sponsor of such applicable medical imaging device has provided to the sponsor of the contrast agent a right of reference.
For purposes of this subsection— the term new 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(q), but that is not described in the approved labeling of the contrast agent; and the term applicable medical imaging device and contrast agent have the meanings given such terms in section 520(q). .
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Sec. 802
Applications for approval of contrast agents intended for use with certain diagnostic medical imaging devices
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