I 
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 diag-
nostic imaging devices intended for use with contrast 
agents. 
Be it enacted by the Senate and House of Representa-
tives 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’’. 
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SEC. 2. APPROVAL OF APPLICATIONS FOR CERTAIN DIAG-
NOSTIC 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 sec-
tion 515 with respect to an applicable medical imaging de-
vice, or, in the case of an applicable medical imaging de-
vice 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 noti-
fication 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 con-
trast agent; 
‘‘(B) in a region, organ, or system of the body 
that is different from those described in the ap-
proved labeling of the contrast agent, unless the Sec-
retary determines, based on information contained in 
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the application or notification involved, that the dif-
ference 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 ultra-
sonic, ionizing radiation, or magnetic resonance 
imagine modality) that is different from those de-
scribed in the approved labeling of the contrast 
agent. 
‘‘(2) The agency center charged with premarket re-
view 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 de-
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vice that is the subject of such review a right of ref-
erence 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 (in-
cluding 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 de-
vice’ means a device intended to be used in conjunc-
tion with a contrast agent (or class of contrast 
agents) for a use that is not described in the indica-
tions and usage section of the approved labeling of 
such contrast agent (or the approved labeling of any 
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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 enhanc-
ing the contrast between a target tissue, struc-
ture, 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 
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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 sub-
mitted 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 de-
scribed in the approved labeling of an applicable 
medical imaging device described in section 
520(p), but that is not described in the indica-
tions and usage section of the approved labeling 
of the contrast agent; and 
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‘‘(B) the term ‘applicable medical imaging 
device’ and ‘contrast agent’ have the meanings 
given such terms in section 520(p).’’. 
Æ 
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