Legis Daily

DEVICE Act of 2021

USA117th CongressHR-887| House 
| Updated: 2/8/2021
Ted Lieu

Ted Lieu

Democratic Representative

California

Cosponsors (2)
Eleanor Holmes Norton (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 2021 or the DEVICE Act of 2021 This bill addresses design changes and reprocessing of medical devices. Specifically, medical device manufacturers must notify the Food and Drug Administration (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. (Reprocessing of medical devices is the process for cleaning and sterilizing or disinfecting devices for reuse.) A device may not be sold if the manufacturer violates these notification requirements.
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Timeline

Bill from Previous Congress

HR 116-818
DEVICE Act of 2019
Feb 5, 2021
Introduced in House
Feb 5, 2021
Referred to the House Committee on Energy and Commerce.
Feb 8, 2021
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-818
    DEVICE Act of 2019


  • February 5, 2021
    Introduced in House


  • February 5, 2021
    Referred to the House Committee on Energy and Commerce.


  • February 8, 2021
    Referred to the Subcommittee on Health.

Health

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

DEVICE Act of 2021

USA117th CongressHR-887| House 
| Updated: 2/8/2021
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2021 or the DEVICE Act of 2021 This bill addresses design changes and reprocessing of medical devices. Specifically, medical device manufacturers must notify the Food and Drug Administration (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. (Reprocessing of medical devices is the process for cleaning and sterilizing or disinfecting devices for reuse.) A device may not be sold if the manufacturer violates these notification requirements.
View Full Text

Suggested Questions

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

Timeline

Bill from Previous Congress

HR 116-818
DEVICE Act of 2019
Feb 5, 2021
Introduced in House
Feb 5, 2021
Referred to the House Committee on Energy and Commerce.
Feb 8, 2021
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-818
    DEVICE Act of 2019


  • February 5, 2021
    Introduced in House


  • February 5, 2021
    Referred to the House Committee on Energy and Commerce.


  • February 8, 2021
    Referred to the Subcommittee on Health.
Ted Lieu

Ted Lieu

Democratic Representative

California

Cosponsors (2)
Eleanor Holmes Norton (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