[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2009 Introduced in House (IH)]

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115th CONGRESS
  1st Session
                                H. R. 2009

 To amend the Federal Food, Drug, and Cosmetic Act to provide clarity 
 with respect to the regulation of diagnostic imaging devices intended 
                     for use with contrast agents.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 6, 2017

 Mr. Costello of Pennsylvania (for himself and Mr. Peters) introduced 
 the following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to provide clarity 
 with respect to the regulation of diagnostic imaging devices intended 
                     for use with contrast agents.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Fostering Innovation in Medical 
Imaging Act of 2017''.

SEC. 2. APPROVAL OF APPLICATIONS FOR CERTAIN DIAGNOSTIC MEDICAL IMAGING 
              DEVICES.

    Section 520 of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 
360j) is amended by adding at the end the following:

   ``Diagnostic Imaging Devices Intended for Use With Contrast Agents

    ``(p)(1) The Secretary may, subject to the succeeding provisions of 
this subsection, approve an application (or supplement to such an 
application) submitted under section 515 with respect to an applicable 
medical imaging device, or, in the case of an applicable medical 
imaging device for which a notification was submitted under section 
510(k) (or a supplement to such a notification), may make a substantial 
equivalence determination with respect to such applicable medical 
imaging device, if the indications and conditions of use proposed in 
such application or notification do not involve the use of a contrast 
agent--
            ``(A) in a concentration, rate of administration, or route 
        of administration that is different from those described in the 
        approved labeling of the contrast agent;
            ``(B) in a region, organ, or system of the body that is 
        different from those described in the approved labeling of the 
        contrast agent, unless the Secretary determines, based on 
        information contained in the application or notification 
        involved, that the difference does not reduce the safety of the 
        contrast agent when used with the device;
            ``(C) in a new patient population for which the contrast 
        agent is determined by the Secretary to pose an increased risk; 
        or
            ``(D) in an imaging modality (such as an ultrasonic, 
        ionizing radiation, or magnetic resonance imagine modality) 
        that is different from those described in the approved labeling 
        of the contrast agent.
    ``(2) 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 (1). In conducting 
such review, such agency center may--
            ``(A) consult with the agency center charged with the 
        premarket review of drugs and biological products; 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; 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.''.

SEC. 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).''.
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