H.R. 2009 – Fostering Innovation in Medical Imaging Act of 2017

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Updated April 15, 2026 at 2:37 PM UTC

The Fostering Innovation in Medical Imaging Act of 2017 updates the Federal Food, Drug, and Cosmetic Act to clarify how the FDA regulates diagnostic imaging devices that are used with contrast agents. It sets rules for approving such devices and for approving new uses of contrast agents, aiming to streamline reviews while maintaining safety. The changes affect manufacturers of imaging equipment and contrast agents, as well as the FDA centers that review them.

Key Provisions

Allows the FDA Secretary to approve imaging device applications (or 510(k) notifications) even when the proposed use of a contrast agent differs from its approved labeling in concentration, route, body region, patient population, or imaging modality, provided safety is not reduced.
Gives primary review authority to the FDA center that handles devices, but permits that center to consult the drug‑review center and to use data supplied by the contrast‑agent sponsor.
Excludes device applications from the drug‑approval evidentiary standards in sections 505(d) and (e), keeping device review under the existing device pathways.
Requires device applications that involve contrast agents to name the agent by its trade or brand name rather than by a drug class.
Defines “applicable medical imaging device” as a device used with a contrast agent in a way not described in the agent’s labeling, and defines “contrast agent” as a drug approved under section 505 that enhances imaging contrast.
Lets contrast‑agent sponsors submit supplements to seek approval for new contrast indications tied to specific imaging devices, with the drug‑review center consulting the device‑review center and using device data when available.

Legislative Activity

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2 earlier actions

HouseCommittee Latest Action

Referred to the Subcommittee on Health.

Health Subcommittee

April 7, 2017

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HouseIntro Referral

Introduced in House

April 6, 2017

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

April 6, 2017

HouseCommittee

Referred to the Subcommittee on Health.

Health Subcommittee

April 7, 2017

Floor Debate

3 members

What members said about H.R. 2009 on the floor

1 Republican2 Democrats

Rep. Darin LaHoodR-IL-18 · Jul 11, 2017

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 1404) to provide for the conveyance of certain land inholdings owned by the United States to the Tucson Unified School District and to…

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 1404) to provide for the conveyance of certain land inholdings owned by the United States to the Tucson Unified School District and to the Pascua Yaqui Tribe of Arizona.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days to revise and extend their remarks and include extraneous material on the bill under consideration.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise today in support of H.R. 1404, the Pascua Yaqui Tribe Land Conveyance Act, sponsored by the gentleman from Arizona (Mr. Grijalva), the ranking member on the National Resources Committee.

H.R. 1404 would authorize a land exchange involving the Tribe, the Tucson Unified School District, and the Department of the Interior.

Under the bill, a 39.65-acre parcel of land currently held by the district shall be placed in trust for the benefit of the Tribe if the district relinquishes all right, title, and interest to it.

A 13.24-acre parcel of land shall be sold by the U.S. to the district at fair market value, and a Federal interest of 27.5 acres of land held by the district shall be cleared in exchange for the district paying the appraised value of the Federal interest. The Federal interest is a reversionary interest imposed on certain land patented to the district under the Recreation and Public Purposes Act of 1926.

All transfers under the bill are subject to valid existing rights. Gaming pursuant to the Indian Gaming Regulatory Act would be prohibited on lands taken into trust under the bill.

This bill is substantively similar to the bill the House passed during the 114th Congress.

Mr. Speaker, I thank the sponsor. I urge adoption of the measure, and I reserve the balance of my time.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I have no additional speakers, and I reserve the balance of my time.

Mr. Speaker, I urge adoption of this legislation, and I yield back the balance of my time.

Rep. Jimmy PanettaD-CA-20 · Jul 11, 2017

Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, this legislation represents the final part of a collaborative land agreement between the Pascua Yaqui Tribe, located in southern…

Rep. Raúl M. GrijalvaD-AZ-3 · Jul 11, 2017

Mr. Speaker, I thank the gentleman from California for yielding. Mr. Speaker, H.R. 1404, as was stated by my two colleagues, is a culmination of a longstanding land agreement between Tucson Unified…

Bill Text

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Introduced in HouseIssued April 6, 2017

I

115th CONGRESS

1st Session

H. R. 2009

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.

Short title

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

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:

(p)

Diagnostic imaging devices intended for use with contrast agents

(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.

.

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).

.