,i #aaeth ,,congress #ast ,session ,h4 ,r4 #bjji ,,in ,,the ,,house ,,of ,,representatives ,april #f1 #bjag,mr4 ,costello of ,pennsylvania 7for himself and ,mr4 ,peters7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents4 #a4 ,short title ,this ,act may be cited as the ,fostering ,innovation in ,medical ,imaging ,act of #bjag4 #b4 ,approval of applications for certain diagnostic medical imaging devices ,section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#db ,u4,s4,c4 #cfj;j7 is amended by adding at the end the following3 7p7 ,diagnostic imaging devices intended for use with contrast agents 7#a7 ,the ,secretary may1 subject to the succeeding provisions of this subsection1 approve an application 7or supplement to such an application7 submitted under section #eae with respect to an applicable medical imaging device1 or1 in the case of an applicable medical imaging device for which a notification was submitted under section #eaj7k7 7or a supplement to such a notification71 may make a substantial equivalence determination with respect to such applicable medical imaging device1 if the indications and conditions of use proposed in such application or notification do not involve the use of a contrast agent-- 7,a7 in a concentration1 rate of administration1 or route of administration that is different from those described in the approved labeling of the contrast agent2 7,b7 in a region1 organ1 or system of the body that is different from those described in the approved labeling of the contrast agent1 unless the ,secretary determines1 based on information contained in the application or notification involved1 that the difference does not reduce the safety of the contrast agent when used with the device2 7,c7 in a new patient population for which the contrast agent is determined by the ,secretary to pose an increased risk2 or 7,d7 in an imaging modality 7such as an ultrasonic1 ionizing radiation1 or magnetic resonance imagine modality7 that is different from those described in the approved labeling of the contrast agent4 7#b7 ,the agency center charged with premarket review of devices shall have primary jurisdiction with respect to the review of an application or notification described in paragraph 7#a74 ,in conducting such review1 such agency center may-- 7,a7 consult with the agency center charged with the premarket review of drugs and biological products2 and 7,b7 review information and data provided to the ,secretary by the sponsor of a contrast agent in an application submitted under section #eje1 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 use4 7#c7 ,an application submitted under section #eae or a notification submitted under section #eaj7k7 with respect to an applicable medical imaging device shall be subject to the requirements of such respective section1 and shall not be subject to subsection 7d7 or 7e7 of section #eje 7including the substantial evidence standard specified in such subsections74 7#d7 ,an application submitted under section #eae or a notification submitted under section #eaj7k7 with respect to an applicable medical imaging device intended for use in conjunction with a contrast agent to which clause 7ii7 or 7iii7 of section #eje7;c77#c77;,e7 applies shall refer to such contrast agent by trade or brand name1 rather than to a class of drugs4 7#e7 ,for purposes of this subsection and section #eje7y7-- 7,a7 the term applicable medical imaging device means a device intended to be used in conjunction with a contrast agent 7or class of contrast agents7 for a use that is not described in the indications and usage section of the approved labeling of such contrast agent 7or the approved labeling of any contrast agent in the same class as such contrast agent72 and 7,b7 the term contrast agent means a drug that-- 7i7 is a radioactive drug 7as defined in section #caj4c7n7 of title #ba1 ,code of ,federal ,regulations72 or 7ii7 7,i7 is approved under section #eje2 7,,ii7 is intended for use in conjunction with a diagnostic imaging device2 and 7,,iii7 achieves its intended use by enhancing the contrast between a target tissue1 structure1 or fluid and the surrounding tissues or structures within the body4 4 #c4 ,applications for approval of contrast agents intended for use with certain diagnostic medical imaging devices ,section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#db ,u4,s4,c4 #cee7 is amended by adding at the end the following3 7y7 ,contrast agents intended for use with applicable medical imaging devices 7#a7 ,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 indication4 7#b7 ,in reviewing a supplement submitted under this subsection1 the agency center charged with the premarket review of drugs may-- 7,a7 consult with the center charged with the premarket review of devices2 and 7,b7 review information and data submitted to the ,secretary by the sponsor of an applicable medical imaging device pursuant to section #eae or #eaj7k71 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 use4 7#c7 ,for purposes of this subsection-- 7,a7 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 #ebj7p71 but that is not described in the indications and usage section of the approved labeling of the contrast agent2 and 7,b7 the term applicable medical imaging device and contrast agent have the meanings given such terms in section #ebj7p74 4