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DEVICE Act of 2019

USA116th CongressHR-818| House 
| Updated: 1/29/2019
Ted Lieu

Ted Lieu

Democratic Representative

California

Cosponsors (4)
Raúl M. Grijalva (Democratic)Eleanor Holmes Norton (Democratic)Elijah E. Cummings (Democratic)Judy Chu (Democratic)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2019 or the DEVICE Act of 2019 This bill addresses design changes and reprocessing of medical devices. Reprocessing of medical devices is the process to clean and sterilize or disinfect devices for reuse. Specifically, medical device manufacturers must notify the Food and Drug Administration (FDA) (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device. A device may not be sold if the manufacturer violates these notification requirements. Rapid assessment tests intended to ensure the proper reprocessing of reusable medical devices are defined as medical devices. The FDA must publish a list of the types of rapid assessment tests for which premarket notification must include validated instructions for use and validation data.
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Timeline
Jan 28, 2019
Introduced in House
Jan 28, 2019
Referred to the House Committee on Energy and Commerce.
Jan 29, 2019
Referred to the Subcommittee on Health.
  • January 28, 2019
    Introduced in House


  • January 28, 2019
    Referred to the House Committee on Energy and Commerce.


  • January 29, 2019
    Referred to the Subcommittee on Health.

Health

Business recordsDrug safety, medical device, and laboratory regulationGovernment information and archivesHealth technology, devices, supplies

DEVICE Act of 2019

USA116th CongressHR-818| House 
| Updated: 1/29/2019
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2019 or the DEVICE Act of 2019 This bill addresses design changes and reprocessing of medical devices. Reprocessing of medical devices is the process to clean and sterilize or disinfect devices for reuse. Specifically, medical device manufacturers must notify the Food and Drug Administration (FDA) (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device. A device may not be sold if the manufacturer violates these notification requirements. Rapid assessment tests intended to ensure the proper reprocessing of reusable medical devices are defined as medical devices. The FDA must publish a list of the types of rapid assessment tests for which premarket notification must include validated instructions for use and validation data.
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Suggested Questions

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Timeline
Jan 28, 2019
Introduced in House
Jan 28, 2019
Referred to the House Committee on Energy and Commerce.
Jan 29, 2019
Referred to the Subcommittee on Health.
  • January 28, 2019
    Introduced in House


  • January 28, 2019
    Referred to the House Committee on Energy and Commerce.


  • January 29, 2019
    Referred to the Subcommittee on Health.
Ted Lieu

Ted Lieu

Democratic Representative

California

Cosponsors (4)
Raúl M. Grijalva (Democratic)Eleanor Holmes Norton (Democratic)Elijah E. Cummings (Democratic)Judy Chu (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Business recordsDrug safety, medical device, and laboratory regulationGovernment information and archivesHealth technology, devices, supplies