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 diagnostic imaging devices intended for use with contrast 

agents. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Fostering Innovation 

5 in Medical Imaging Act of 2017’’. 


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1 SEC. 2. APPROVAL OF APPLICATIONS FOR CERTAIN DIAG2 NOSTIC MEDICAL IMAGING DEVICES. 

3 Section 520 of the Federal Food, Drug, and Cosmetic 

4 Act (42 U.S.C. 360j) is amended by adding at the end 

5 the following: 

6 ‘‘Diagnostic Imaging Devices Intended for Use With 

7 Contrast Agents 

8 ‘‘(p)(1) The Secretary may, subject to the succeeding 

9 provisions of this subsection, approve an application (or 

10 supplement to such an application) submitted under sec11 tion 515 with respect to an applicable medical imaging de12 vice, or, in the case of an applicable medical imaging de13 vice for which a notification was submitted under section 

14 510(k) (or a supplement to such a notification), may make 

15 a substantial equivalence determination with respect to 

16 such applicable medical imaging device, if the indications 

17 and conditions of use proposed in such application or noti18 fication do not involve the use of a contrast agent— 

19 ‘‘(A) in a concentration, rate of administration, 

20 or route of administration that is different from 

21 those described in the approved labeling of the con22 trast agent; 

23 ‘‘(B) in a region, organ, or system of the body 

24 that is different from those described in the ap25 proved labeling of the contrast agent, unless the Sec26 retary determines, based on information contained in 


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1 the application or notification involved, that the dif2 ference does not reduce the safety of the contrast 

3 agent when used with the device; 

4 ‘‘(C) in a new patient population for which the 

5 contrast agent is determined by the Secretary to 

6 pose an increased risk; or 

7 ‘‘(D) in an imaging modality (such as an ultra8 sonic, ionizing radiation, or magnetic resonance 

9 imagine modality) that is different from those de10 scribed in the approved labeling of the contrast 

11 agent. 

12 ‘‘(2) The agency center charged with premarket re13 view of devices shall have primary jurisdiction with respect 

14 to the review of an application or notification described 

15 in paragraph (1). In conducting such review, such agency 

16 center may— 

17 ‘‘(A) consult with the agency center charged 

18 with the premarket review of drugs and biological 

19 products; and 

20 ‘‘(B) review information and data provided to 

21 the Secretary by the sponsor of a contrast agent in 

22 an application submitted under section 505, so long 

23 as the sponsor of such contrast agent has provided 

24 to the sponsor of the applicable medical imaging deVerDate Sep 11 2014 01:24 Apr 14, 2017 Jkt 069200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2009.IH H2009

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1 vice that is the subject of such review a right of ref2 erence or use. 

3 ‘‘(3) An application submitted under section 515 or 

4 a notification submitted under section 510(k) with respect 

5 to an applicable medical imaging device shall be subject 

6 to the requirements of such respective section, and shall 

7 not be subject to subsection (d) or (e) of section 505 (in8 cluding the substantial evidence standard specified in such 

9 subsections). 

10 ‘‘(4) An application submitted under section 515 or 

11 a notification submitted under section 510(k) with respect 

12 to an applicable medical imaging device intended for use 

13 in conjunction with a contrast agent to which clause (ii) 

14 or (iii) of section 505(c)(3)(E) applies shall refer to such 

15 contrast agent by trade or brand name, rather than to 

16 a class of drugs. 

17 ‘‘(5) For purposes of this subsection and section 

18 505(y)— 

19 ‘‘(A) the term ‘applicable medical imaging de20 vice’ means a device intended to be used in conjunc21 tion with a contrast agent (or class of contrast 

22 agents) for a use that is not described in the indica23 tions and usage section of the approved labeling of 

24 such contrast agent (or the approved labeling of any 


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1 contrast agent in the same class as such contrast 

2 agent); and 

3 ‘‘(B) the term ‘contrast agent’ means a drug 

4 that— 

5 ‘‘(i) is a radioactive drug (as defined in 

6 section 310.3(n) of title 21, Code of Federal 

7 Regulations); or 

8 ‘‘(ii)(I) is approved under section 505; 

9 ‘‘(II) is intended for use in conjunction 

10 with a diagnostic imaging device; and 

11 ‘‘(III) achieves its intended use by enhanc12 ing the contrast between a target tissue, struc13 ture, or fluid and the surrounding tissues or 

14 structures within the body.’’. 

15 SEC. 3. APPLICATIONS FOR APPROVAL OF CONTRAST 

16 AGENTS INTENDED FOR USE WITH CERTAIN 

17 DIAGNOSTIC MEDICAL IMAGING DEVICES. 

18 Section 505 of the Federal Food, Drug, and Cosmetic 

19 Act (42 U.S.C. 355) is amended by adding at the end the 

20 following: 

21 ‘‘(y) CONTRAST AGENTS INTENDED FOR USE WITH

22 APPLICABLE MEDICAL IMAGING DEVICES.— 

23 ‘‘(1) The sponsor of a contrast agent for which 

24 an application has been approved under this section 

25 may submit a supplement to the application seeking 


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1 approval for the use of the contrast agent for a new 

2 contrast indication. 

3 ‘‘(2) In reviewing a supplement submitted 

4 under this subsection, the agency center charged 

5 with the premarket review of drugs may— 

6 ‘‘(A) consult with the center charged with 

7 the premarket review of devices; and 

8 ‘‘(B) review information and data sub9 mitted to the Secretary by the sponsor of an 

10 applicable medical imaging device pursuant to 

11 section 515 or 510(k), so long as the sponsor 

12 of such applicable medical imaging device has 

13 provided to the sponsor of the contrast agent a 

14 right of reference or use. 

15 ‘‘(3) For purposes of this subsection— 

16 ‘‘(A) the term ‘new contrast indication’ 

17 means a use of a contrast agent that is de18 scribed in the approved labeling of an applicable 

19 medical imaging device described in section 

20 520(p), but that is not described in the indica21 tions and usage section of the approved labeling 

22 of the contrast agent; and 


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1 ‘‘(B) the term ‘applicable medical imaging 

2 device’ and ‘contrast agent’ have the meanings 

3 given such terms in section 520(p).’’. 

Æ 


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