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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.

USA115th CongressHR-2009| House 
| Updated: 4/7/2017
Ryan A. Costello

Ryan A. Costello

Republican Representative

Pennsylvania

Cosponsors (2)
Suzan K. DelBene (Democratic)Scott H. Peters (Democratic)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline
Apr 6, 2017
Introduced in House
Apr 6, 2017
Referred to the House Committee on Energy and Commerce.
Apr 7, 2017
Referred to the Subcommittee on Health.
  • April 6, 2017
    Introduced in House


  • April 6, 2017
    Referred to the House Committee on Energy and Commerce.


  • April 7, 2017
    Referred to the Subcommittee on Health.

Health

Drug safety, medical device, and laboratory regulationHealth technology, devices, suppliesMedical tests and diagnostic methodsRadiation

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.

USA115th CongressHR-2009| House 
| Updated: 4/7/2017
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Apr 6, 2017
Introduced in House
Apr 6, 2017
Referred to the House Committee on Energy and Commerce.
Apr 7, 2017
Referred to the Subcommittee on Health.
  • April 6, 2017
    Introduced in House


  • April 6, 2017
    Referred to the House Committee on Energy and Commerce.


  • April 7, 2017
    Referred to the Subcommittee on Health.
Ryan A. Costello

Ryan A. Costello

Republican Representative

Pennsylvania

Cosponsors (2)
Suzan K. DelBene (Democratic)Scott H. Peters (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationHealth technology, devices, suppliesMedical tests and diagnostic methodsRadiation