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United States · Bill · HR

H.R. 1328 (118th)

Medical Device Nonvisual Accessibility Act of 2023

referredUnited States· United States Congress· EN

Introduced

1 March 2023

Last action

10 March 2023 · Referred

Status

Referred to the Subcommittee on Health.

Sponsors

Rep. Schakowsky, Janice D. [D-IL-9], Rep. Trone, David J. [D-MD-6], Rep. Veasey, Marc A. [D-TX-33], Rep. Bishop, Sanford D. [D-GA-2], Rep. Panetta, Jimmy [D-CA-19], Rep. Sarbanes, John P. [D-MD-3], Rep. Pocan, Mark [D-WI-2], Rep. Quigley, Mike [D-IL-5], Rep. Smith, Adam [D-WA-9], Rep. Ruppersberger, C. A. Dutch [D-MD-2], Rep. Bush, Cori [D-MO-1], Rep. Sessions, Pete [R-TX-17], Rep. Larson, John B. [D-CT-1], Rep. Lee, Barbara [D-CA-12], Rep. Grijalva, Raúl M. [D-AZ-7], Rep. Casten, Sean [D-IL-6], Rep. García, Jesús G. "Chuy" [D-IL-4], Rep. Rutherford, John H. [R-FL-5], Rep. Lynch, Stephen F. [D-MA-8], Rep. Titus, Dina [D-NV-1], Sen. Blunt Rochester, Lisa [D-DE], Rep. Cherfilus-McCormick, Sheila [D-FL-20], Rep. Connolly, Gerald E. [D-VA-11], Rep. Case, Ed [D-HI-1], Rep. Keating, William R. [D-MA-9], Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. Davis, Danny K. [D-IL-7], Rep. Tlaib, Rashida [D-MI-12], Rep. Craig, Angie [D-MN-2], Rep. Sewell, Terri A. [D-AL-7], Rep. Hayes, Jahana [D-CT-5], Rep. Kildee, Daniel T. [D-MI-5], Rep. Kuster, Ann M. [D-NH-2], Rep. DeSaulnier, Mark [D-CA-10], Rep. Pappas, Chris [D-NH-1], Rep. Dingell, Debbie [D-MI-6], Rep. Watson Coleman, Bonnie [D-NJ-12], Rep. Tonko, Paul [D-NY-20], Rep. Balint, Becca [D-VT-At Large], Rep. Castor, Kathy [D-FL-14], Rep. Bacon, Don [R-NE-2], Rep. Tokuda, Jill N. [D-HI-2], Rep. Krishnamoorthi, Raja [D-IL-8], Rep. Mrvan, Frank J. [D-IN-1], Rep. McClellan, Jennifer L. [D-VA-4], Rep. Beatty, Joyce [D-OH-3], Rep. Kilmer, Derek [D-WA-6], Rep. Davids, Sharice [D-KS-3]

Subjects

Healthcare

Source updated

5 December 2025

Healthcare

Official sourceDownload fileView documentsShare

Summary

Medical Device Nonvisual Accessibility Act of 2023 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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

  1. 1 March 2023

    Introduced

    Referred to the House Committee on Energy and Commerce.

    Source: IntroReferral

  2. 1 March 2023

    Introduced

    Introduced in House

    Source: IntroReferral

  3. 1 March 2023

    Introduced

    Introduced in House

    Source: IntroReferral

  4. 10 March 2023

    Referred

    Referred to the Subcommittee on Health.

    Source: Committee

Votes

No vote records are attached yet.

Versions

Documents

3 official files

Introduced in House (text)

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  • Introduced in House (text)

    Introduced in House · EN · 1 March 2023

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  • Introduced in House (PDF)

    Introduced in House · EN · 1 March 2023

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  • Introduced in House

    summary · EN · 1 March 2023

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Sponsors

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Sources

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