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Medical Device Nonvisual Accessibility Act of 2023

USA118th CongressHR-1328| House 
| Updated: 3/10/2023
Janice D. Schakowsky

Janice D. Schakowsky

Democratic Representative

Illinois

Cosponsors (85)
Becca Balint (Democratic)John Garamendi (Democratic)Jonathan L. Jackson (Democratic)Chris Pappas (Democratic)Marc A. Veasey (Democratic)Barbara Lee (Democratic)Robin L. Kelly (Democratic)Raúl M. Grijalva (Democratic)Mark Pocan (Democratic)Joyce Beatty (Democratic)Lisa Blunt Rochester (Democratic)Mike Garcia (Republican)Jennifer L. McClellan (Democratic)David J. Trone (Democratic)Ed Case (Democratic)Emanuel Cleaver (Democratic)Darren Soto (Democratic)Derek Kilmer (Democratic)Sanford D. Bishop (Democratic)C. A. Dutch Ruppersberger (Democratic)Juan Vargas (Democratic)Terri A. Sewell (Democratic)Jimmy Panetta (Democratic)Dina Titus (Democratic)Pete Sessions (Republican)Maxwell Frost (Democratic)Debbie Dingell (Democratic)Melanie A. Stansbury (Democratic)Steve Cohen (Democratic)Suzan K. DelBene (Democratic)Paul Tonko (Democratic)Angie Craig (Democratic)Donald G. Davis (Democratic)John P. Sarbanes (Democratic)Frank J. Mrvan (Democratic)Danny K. Davis (Democratic)Daniel T. Kildee (Democratic)Thomas H. Kean (Republican)Ann M. Kuster (Democratic)Sheila Cherfilus-McCormick (Democratic)Don Bacon (Republican)André Carson (Democratic)John B. Larson (Democratic)Stephen F. Lynch (Democratic)Mark DeSaulnier (Democratic)Jill N. Tokuda (Democratic)Joseph D. Morelle (Democratic)Glenn Ivey (Democratic)Jahana Hayes (Democratic)Raja Krishnamoorthi (Democratic)James A. Himes (Democratic)Jerrold Nadler (Democratic)Brittany Pettersen (Democratic)Mark Takano (Democratic)John H. Rutherford (Republican)Kathy Castor (Democratic)Sharice Davids (Democratic)Brad Sherman (Democratic)Bonnie Watson Coleman (Democratic)Henry Cuellar (Democratic)Jamie Raskin (Democratic)Joe Neguse (Democratic)Mike Quigley (Democratic)Sean Casten (Democratic)Adam Smith (Democratic)Julia Brownley (Democratic)William R. Keating (Democratic)Seth Magaziner (Democratic)Rick Larsen (Democratic)Brian K. Fitzpatrick (Republican)Colin Z. Allred (Democratic)Bennie G. Thompson (Democratic)Yadira Caraveo (Democratic)Josh Gottheimer (Democratic)Jesús G. "Chuy" García (Democratic)Kevin Mullin (Democratic)Jason Crow (Democratic)Valerie P. Foushee (Democratic)Rashida Tlaib (Democratic)Kweisi Mfume (Democratic)Lloyd Doggett (Democratic)Debbie Wasserman Schultz (Democratic)Gerald E. Connolly (Democratic)Susan Wild (Democratic)Cori Bush (Democratic)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline

Bill from Previous Congress

HR 117-4853
Medical Device Nonvisual Accessibility Act of 2021
Mar 1, 2023
Introduced in House
Mar 1, 2023
Referred to the House Committee on Energy and Commerce.
Mar 10, 2023
Referred to the Subcommittee on Health.
Jan 18, 2024

Latest Companion Bill Action

S 118-3621
Introduced in Senate
  • Bill from Previous Congress

    HR 117-4853
    Medical Device Nonvisual Accessibility Act of 2021


  • March 1, 2023
    Introduced in House


  • March 1, 2023
    Referred to the House Committee on Energy and Commerce.


  • March 10, 2023
    Referred to the Subcommittee on Health.


  • January 18, 2024

    Latest Companion Bill Action

    S 118-3621
    Introduced in Senate

Health

Related Bills

  • S 118-3621: Medical Device Nonvisual Accessibility Act of 2024
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 2023

USA118th CongressHR-1328| House 
| Updated: 3/10/2023
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.
View Full Text

Suggested Questions

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

Timeline

Bill from Previous Congress

HR 117-4853
Medical Device Nonvisual Accessibility Act of 2021
Mar 1, 2023
Introduced in House
Mar 1, 2023
Referred to the House Committee on Energy and Commerce.
Mar 10, 2023
Referred to the Subcommittee on Health.
Jan 18, 2024

Latest Companion Bill Action

S 118-3621
Introduced in Senate
  • Bill from Previous Congress

    HR 117-4853
    Medical Device Nonvisual Accessibility Act of 2021


  • March 1, 2023
    Introduced in House


  • March 1, 2023
    Referred to the House Committee on Energy and Commerce.


  • March 10, 2023
    Referred to the Subcommittee on Health.


  • January 18, 2024

    Latest Companion Bill Action

    S 118-3621
    Introduced in Senate
Janice D. Schakowsky

Janice D. Schakowsky

Democratic Representative

Illinois

Cosponsors (85)
Becca Balint (Democratic)John Garamendi (Democratic)Jonathan L. Jackson (Democratic)Chris Pappas (Democratic)Marc A. Veasey (Democratic)Barbara Lee (Democratic)Robin L. Kelly (Democratic)Raúl M. Grijalva (Democratic)Mark Pocan (Democratic)Joyce Beatty (Democratic)Lisa Blunt Rochester (Democratic)Mike Garcia (Republican)Jennifer L. McClellan (Democratic)David J. Trone (Democratic)Ed Case (Democratic)Emanuel Cleaver (Democratic)Darren Soto (Democratic)Derek Kilmer (Democratic)Sanford D. Bishop (Democratic)C. A. Dutch Ruppersberger (Democratic)Juan Vargas (Democratic)Terri A. Sewell (Democratic)Jimmy Panetta (Democratic)Dina Titus (Democratic)Pete Sessions (Republican)Maxwell Frost (Democratic)Debbie Dingell (Democratic)Melanie A. Stansbury (Democratic)Steve Cohen (Democratic)Suzan K. DelBene (Democratic)Paul Tonko (Democratic)Angie Craig (Democratic)Donald G. Davis (Democratic)John P. Sarbanes (Democratic)Frank J. Mrvan (Democratic)Danny K. Davis (Democratic)Daniel T. Kildee (Democratic)Thomas H. Kean (Republican)Ann M. Kuster (Democratic)Sheila Cherfilus-McCormick (Democratic)Don Bacon (Republican)André Carson (Democratic)John B. Larson (Democratic)Stephen F. Lynch (Democratic)Mark DeSaulnier (Democratic)Jill N. Tokuda (Democratic)Joseph D. Morelle (Democratic)Glenn Ivey (Democratic)Jahana Hayes (Democratic)Raja Krishnamoorthi (Democratic)James A. Himes (Democratic)Jerrold Nadler (Democratic)Brittany Pettersen (Democratic)Mark Takano (Democratic)John H. Rutherford (Republican)Kathy Castor (Democratic)Sharice Davids (Democratic)Brad Sherman (Democratic)Bonnie Watson Coleman (Democratic)Henry Cuellar (Democratic)Jamie Raskin (Democratic)Joe Neguse (Democratic)Mike Quigley (Democratic)Sean Casten (Democratic)Adam Smith (Democratic)Julia Brownley (Democratic)William R. Keating (Democratic)Seth Magaziner (Democratic)Rick Larsen (Democratic)Brian K. Fitzpatrick (Republican)Colin Z. Allred (Democratic)Bennie G. Thompson (Democratic)Yadira Caraveo (Democratic)Josh Gottheimer (Democratic)Jesús G. "Chuy" García (Democratic)Kevin Mullin (Democratic)Jason Crow (Democratic)Valerie P. Foushee (Democratic)Rashida Tlaib (Democratic)Kweisi Mfume (Democratic)Lloyd Doggett (Democratic)Debbie Wasserman Schultz (Democratic)Gerald E. Connolly (Democratic)Susan Wild (Democratic)Cori Bush (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • S 118-3621: Medical Device Nonvisual Accessibility Act of 2024
  • 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