3.0.0 2009 2023-01-11T13:36:02Z 2023-01-11T13:36:02Z House HR 2017-04-06 115 [Congressional Record Volume 163, Number 60 (Thursday, April 6, 2017)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. COSTELLO of Pennsylvania:H.R. 2009.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8 of the United States Constitution[Page H2791]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2017-04-07T14:47:44Z Referred to 2017-04-06T13:14:20Z 2017-04-07 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2017-04-06 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2017-04-06 Introduced in House IntroReferral Intro-H 9 Library of Congress 2017-04-06 Introduced in House IntroReferral 1000 9 Library of Congress C001106 Rep. Costello, Ryan A. [R-PA-6] Ryan Costello R PA A. 6 N P000608 Rep. Peters, Scott H. [D-CA-52] Scott Peters D CA H. 52 2017-04-06 True D000617 Rep. DelBene, Suzan K. [D-WA-1] Suzan DelBene D WA K. 1 2017-04-28 False Health Drug safety, medical device, and laboratory regulation Health technology, devices, supplies Medical tests and diagnostic methods Radiation Health 00 2017-04-06 Introduced in House 2017-12-21T17:24:43Z Fostering Innovation in Medical Imaging Act of 2017

This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to approve a medical imaging device intended to be used with an approved contrast agent when—under specified conditions—the use differs from the approved use of the contrast agent. (Contrast agents are substances used to enhance the visibility of body structures in medical imaging.) The FDA center that reviews medical devices has primary jurisdiction over such reviews.

After authorization of a medical imaging device that makes new use of a contrast agent, the sponsor of the approved contrast agent may submit a supplemental application for the new use of the contrast agent.

]]> Fostering Innovation in Medical Imaging Act of 2017 Display Title Fostering Innovation in Medical Imaging Act of 2017 Official Title as Introduced 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. Introduced in House IH Short Titles as Introduced Fostering Innovation in Medical Imaging Act of 2017 Introduced in House 2017-04-06T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr2009ih/xml/BILLS-115hr2009ih.xml 2017-04-07 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.