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Medical Device Nonvisual Accessibility Act of 2024

USA118th CongressS-3621| Senate 
| Updated: 1/18/2024
Margaret Wood Hassan

Margaret Wood Hassan

Democratic Senator

New Hampshire

Cosponsors (1)
Mike Braun (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Medical Device Nonvisual Accessibility Act of 2024 This bill requires certain medical devices with a digital interface to meet nonvisual accessibility standards established by the Food and Drug Administration (FDA). Specifically, the FDA must establish regulations to require a Class II or Class III medical device with a digital interface to provide a blind or low-vision user access to the same services and information, and generally the same ease of use, as provided to a user who is not low-vision or blind. (The FDA classifies medical devices in three classes. Class I devices are low-risk, Class II devices are moderate-risk, and Class III devices are high-risk.) A Class II or Class III medical device that does not meet the nonvisual accessibility standards established under this bill may not be sold. However, the FDA may waive the bill's requirements for a device upon a showing that applying the standards would fundamentally alter the nature of the device or create an undue hardship for the manufacturer. The bill also does not apply to devices that are intended solely for use by a health care provider or in a setting outside the home.
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Timeline
Mar 10, 2023

Latest Companion Bill Action

HR 118-1328
Referred to the Subcommittee on Health.
Jan 18, 2024
Introduced in Senate
Jan 18, 2024
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • March 10, 2023

    Latest Companion Bill Action

    HR 118-1328
    Referred to the Subcommittee on Health.


  • January 18, 2024
    Introduced in Senate


  • January 18, 2024
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • HR 118-1328: Medical Device Nonvisual Accessibility Act of 2023
Administrative law and regulatory proceduresComputers and information technologyDisability and health-based discriminationFood and Drug Administration (FDA)Health care coverage and accessHealth technology, devices, suppliesPhotography and imaging

Medical Device Nonvisual Accessibility Act of 2024

USA118th CongressS-3621| Senate 
| Updated: 1/18/2024
Medical Device Nonvisual Accessibility Act of 2024 This bill requires certain medical devices with a digital interface to meet nonvisual accessibility standards established by the Food and Drug Administration (FDA). Specifically, the FDA must establish regulations to require a Class II or Class III medical device with a digital interface to provide a blind or low-vision user access to the same services and information, and generally the same ease of use, as provided to a user who is not low-vision or blind. (The FDA classifies medical devices in three classes. Class I devices are low-risk, Class II devices are moderate-risk, and Class III devices are high-risk.) A Class II or Class III medical device that does not meet the nonvisual accessibility standards established under this bill may not be sold. However, the FDA may waive the bill's requirements for a device upon a showing that applying the standards would fundamentally alter the nature of the device or create an undue hardship for the manufacturer. The bill also does not apply to devices that are intended solely for use by a health care provider or in a setting outside the home.
View Full Text

Suggested Questions

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

Timeline
Mar 10, 2023

Latest Companion Bill Action

HR 118-1328
Referred to the Subcommittee on Health.
Jan 18, 2024
Introduced in Senate
Jan 18, 2024
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • March 10, 2023

    Latest Companion Bill Action

    HR 118-1328
    Referred to the Subcommittee on Health.


  • January 18, 2024
    Introduced in Senate


  • January 18, 2024
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Margaret Wood Hassan

Margaret Wood Hassan

Democratic Senator

New Hampshire

Cosponsors (1)
Mike Braun (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 118-1328: Medical Device Nonvisual Accessibility Act of 2023
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresComputers and information technologyDisability and health-based discriminationFood and Drug Administration (FDA)Health care coverage and accessHealth technology, devices, suppliesPhotography and imaging