H.R. 2009 · 115th Congress
Fostering Innovation in Medical Imaging Act of 2017
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Never voted on. It didn't reach a floor vote before the 115th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
CostelloSponsor2 cosponsors · 2 D
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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.
What it does: CRS summary · Introduced in House · Apr 6, 2017
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Fostering Innovation in Medical Imaging Act of 2017
Latest action (Apr 7, 2017): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Apr 6, 2017
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.