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Medical Device Nonvisual Accessibility Act of 2021

USA117th CongressHR-4853| House 
| Updated: 7/30/2021
Janice D. Schakowsky

Janice D. Schakowsky

Democratic Representative

Illinois

Cosponsors (65)
Al Lawson (Democratic)John Garamendi (Democratic)Chris Pappas (Democratic)Marc A. Veasey (Democratic)Barbara Lee (Democratic)Mikie Sherrill (Democratic)Raúl M. Grijalva (Democratic)Mark Pocan (Democratic)Karen Bass (Democratic)James R. Langevin (Democratic)Lisa Blunt Rochester (Democratic)David N. Cicilline (Democratic)David J. Trone (Democratic)Darren Soto (Democratic)John A. Yarmuth (Democratic)Sanford D. Bishop (Democratic)C. A. Dutch Ruppersberger (Democratic)Pete Aguilar (Democratic)David Scott (Democratic)Juan Vargas (Democratic)Troy A. Carter (Democratic)Jimmy Panetta (Democratic)Tony Cárdenas (Democratic)Angie Craig (Democratic)Donald M. Payne (Democratic)John P. Sarbanes (Democratic)Anthony G. Brown (Democratic)Ann Kirkpatrick (Democratic)Frank J. Mrvan (Democratic)Danny K. Davis (Democratic)Peter A. DeFazio (Democratic)Ted Lieu (Democratic)Sheila Cherfilus-McCormick (Democratic)Don Bacon (Republican)John B. Larson (Democratic)Stephen F. Lynch (Democratic)Mark DeSaulnier (Democratic)Joseph D. Morelle (Democratic)G. K. Butterfield (Democratic)Jahana Hayes (Democratic)Raja Krishnamoorthi (Democratic)Josh Harder (Democratic)John H. Rutherford (Republican)Lucy McBath (Democratic)Jamie Raskin (Democratic)Jim Costa (Democratic)Joe Neguse (Democratic)Mike Quigley (Democratic)Cynthia Axne (Democratic)Sean Casten (Democratic)James P. McGovern (Democratic)Adam Smith (Democratic)Ron Kind (Democratic)Marie Newman (Democratic)Deborah K. Ross (Democratic)Linda T. Sánchez (Democratic)Jesús G. "Chuy" García (Democratic)Rashida Tlaib (Democratic)Kweisi Mfume (Democratic)Jaime Herrera Beutler (Republican)Debbie Wasserman Schultz (Democratic)Gerald E. Connolly (Democratic)Grace F. Napolitano (Democratic)Cori Bush (Democratic)Judy Chu (Democratic)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline
Jul 29, 2021
Introduced in House
Jul 29, 2021
Referred to the House Committee on Energy and Commerce.
Jul 30, 2021
Referred to the Subcommittee on Health.
  • July 29, 2021
    Introduced in House


  • July 29, 2021
    Referred to the House Committee on Energy and Commerce.


  • July 30, 2021
    Referred to the Subcommittee on Health.

Health

Medical Device Nonvisual Accessibility Act of 2021

USA117th CongressHR-4853| House 
| Updated: 7/30/2021
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.
View Full Text

Suggested Questions

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

Timeline
Jul 29, 2021
Introduced in House
Jul 29, 2021
Referred to the House Committee on Energy and Commerce.
Jul 30, 2021
Referred to the Subcommittee on Health.
  • July 29, 2021
    Introduced in House


  • July 29, 2021
    Referred to the House Committee on Energy and Commerce.


  • July 30, 2021
    Referred to the Subcommittee on Health.
Janice D. Schakowsky

Janice D. Schakowsky

Democratic Representative

Illinois

Cosponsors (65)
Al Lawson (Democratic)John Garamendi (Democratic)Chris Pappas (Democratic)Marc A. Veasey (Democratic)Barbara Lee (Democratic)Mikie Sherrill (Democratic)Raúl M. Grijalva (Democratic)Mark Pocan (Democratic)Karen Bass (Democratic)James R. Langevin (Democratic)Lisa Blunt Rochester (Democratic)David N. Cicilline (Democratic)David J. Trone (Democratic)Darren Soto (Democratic)John A. Yarmuth (Democratic)Sanford D. Bishop (Democratic)C. A. Dutch Ruppersberger (Democratic)Pete Aguilar (Democratic)David Scott (Democratic)Juan Vargas (Democratic)Troy A. Carter (Democratic)Jimmy Panetta (Democratic)Tony Cárdenas (Democratic)Angie Craig (Democratic)Donald M. Payne (Democratic)John P. Sarbanes (Democratic)Anthony G. Brown (Democratic)Ann Kirkpatrick (Democratic)Frank J. Mrvan (Democratic)Danny K. Davis (Democratic)Peter A. DeFazio (Democratic)Ted Lieu (Democratic)Sheila Cherfilus-McCormick (Democratic)Don Bacon (Republican)John B. Larson (Democratic)Stephen F. Lynch (Democratic)Mark DeSaulnier (Democratic)Joseph D. Morelle (Democratic)G. K. Butterfield (Democratic)Jahana Hayes (Democratic)Raja Krishnamoorthi (Democratic)Josh Harder (Democratic)John H. Rutherford (Republican)Lucy McBath (Democratic)Jamie Raskin (Democratic)Jim Costa (Democratic)Joe Neguse (Democratic)Mike Quigley (Democratic)Cynthia Axne (Democratic)Sean Casten (Democratic)James P. McGovern (Democratic)Adam Smith (Democratic)Ron Kind (Democratic)Marie Newman (Democratic)Deborah K. Ross (Democratic)Linda T. Sánchez (Democratic)Jesús G. "Chuy" García (Democratic)Rashida Tlaib (Democratic)Kweisi Mfume (Democratic)Jaime Herrera Beutler (Republican)Debbie Wasserman Schultz (Democratic)Gerald E. Connolly (Democratic)Grace F. Napolitano (Democratic)Cori Bush (Democratic)Judy Chu (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

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