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United States · Bill · HR

H.R. 4853 (117th)

Medical Device Nonvisual Accessibility Act of 2021

referredUnited States· United States Congress· EN

Introduced

29 July 2021

Last action

30 July 2021 · Referred

Status

Referred to the Subcommittee on Health.

Sponsors

Rep. Schakowsky, Janice D. [D-IL-9], Rep. Lee, Barbara [D-CA-12], Rep. Pocan, Mark [D-WI-2], Rep. Ross, Deborah K. [D-NC-2], Rep. Connolly, Gerald E. [D-VA-11], Rep. Morelle, Joseph D. [D-NY-25], Rep. Cárdenas, Tony [D-CA-29], Rep. Smith, Adam [D-WA-9], Rep. Sherrill, Mikie [D-NJ-11], Rep. Grijalva, Raúl M. [D-AZ-7], Rep. Casten, Sean [D-IL-6], Rep. Payne, Donald M., Jr. [D-NJ-10], Rep. Axne, Cynthia [D-IA-3], Rep. Sánchez, Linda T. [D-CA-38], Rep. Pappas, Chris [D-NH-1], Rep. Herrera Beutler, Jaime [R-WA-3], Rep. Soto, Darren [D-FL-9], Rep. Panetta, Jimmy [D-CA-19], Rep. Kind, Ron [D-WI-3], Rep. Costa, Jim [D-CA-21], Rep. Mfume, Kweisi [D-MD-7], Rep. Mrvan, Frank J. [D-IN-1], Rep. Krishnamoorthi, Raja [D-IL-8], Rep. Neguse, Joe [D-CO-2], Rep. Bishop, Sanford D. [D-GA-2], Rep. Aguilar, Pete [D-CA-33], Rep. Raskin, Jamie [D-MD-8], Rep. Yarmuth, John A. [D-KY-3], Rep. Kirkpatrick, Ann [D-AZ-2], Rep. Davis, Danny K. [D-IL-7], Rep. Chu, Judy [D-CA-28], Rep. Vargas, Juan [D-CA-52], Rep. Hayes, Jahana [D-CT-5], David Scott, Rep. Harder, Josh [D-CA-9], Marie Newman, Rep. Garamendi, John [D-CA-8], Rep. Tlaib, Rashida [D-MI-12], Rep. Lieu, Ted [D-CA-36], Rep. Langevin, James R. [D-RI-2], Rep. Butterfield, G. K. [D-NC-1], Rep. Bacon, Don [R-NE-2], Rep. Wasserman Schultz, Debbie [D-FL-25], Rep. DeFazio, Peter A. [D-OR-4], Rep. Lynch, Stephen F. [D-MA-8], Rep. Veasey, Marc A. [D-TX-33], Rep. Bass, Karen [D-CA-37], Rep. McBath, Lucy [D-GA-6]

Subjects

Healthcare

Source updated

3 January 2025

Healthcare

Official sourceDownload fileView documentsShare

Summary

Medical Device Nonvisual Accessibility Act of 2021 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.

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

Timeline

  1. 29 July 2021

    Introduced

    Referred to the House Committee on Energy and Commerce.

    Source: IntroReferral

  2. 29 July 2021

    Introduced

    Introduced in House

    Source: IntroReferral

  3. 29 July 2021

    Introduced

    Introduced in House

    Source: IntroReferral

  4. 30 July 2021

    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 · 29 July 2021

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  • Introduced in House (PDF)

    Introduced in House · EN · 29 July 2021

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  • Introduced in House

    summary · EN · 29 July 2021

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Sponsors

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Related records

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Sources

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