HR 4853 United States House · 117th Congress

Medical Device Nonvisual Accessibility Act of 2021

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.
Bill status in committee 1 of 4 stages cleared
Introduction
Jul 2021
Committee Review
Floor Vote
President
Introduced Jul 29, 2021 Last action Jul 30, 2021
Floor votes

How they voted

No floor votes recorded yet.
Full legislative history

Actions timeline

Total actions
3
Key actions
0
Committee
2
Jul 30, 2021
Committee
Referred to the Subcommittee on Health.
lower
Jul 29, 2021
Committee
Referred to the House Committee on Energy and Commerce.
lower
Jul 29, 2021
Introduced
Introduced in House
lower
1 primary · 65 co-sponsors

Sponsors

Role
Legislator
Party
State
District
P
Photo of Janice D. Schakowsky
Janice D. Schakowsky
DDemocratic
IL
9
Co
Photo of Adam Smith
Adam Smith
DDemocratic
WA
9
Co
Photo of Al Lawson, Jr.
Al Lawson, Jr.
DDemocratic
FL
5
Co
Photo of Angie Craig
Angie Craig
DDemocratic
MN
2
Co
Photo of Ann Kirkpatrick
Ann Kirkpatrick
DDemocratic
AZ
2
Co
Photo of Anthony G. Brown
Anthony G. Brown
DDemocratic
MD
4
Co
Photo of Barbara Lee
Barbara Lee
DDemocratic
CA
12
Co
Photo of C. A. Dutch Ruppersberger
C. A. Dutch Ruppersberger
DDemocratic
MD
2
Co
Photo of Chris Pappas
Chris Pappas
DDemocratic
NH
1
Co
Photo of Cori Bush
Cori Bush
DDemocratic
MO
1
Co
Photo of Cynthia Axne
Cynthia Axne
DDemocratic
IA
3