Federal RuleAug 21
62
DOL Rewrites Disability Rules for 'Merit-Based Opportunity' Push
RuleLabor DepartmentFederal Contract Compliance Programs OfficeSignificant Wallet
119-hr-5605119th CongressWALLET
Medical Device Nonvisual Accessibility Act of 2025
Sponsored By: Representative Schakowsky, Janice D. [D-IL-9]
Introduced
Summary
This bill would create a new nonvisual accessibility standard for certain Class II and III medical devices with digital user interfaces used outside clinical settings. It would require manufacturers to make device screens and apps usable for blind or low-vision people and allow a waiver for undue hardship or fundamental alteration.
Show full summary
- People who are blind or have low vision would get greater access to information, interactions, and privacy when using covered home-use devices through interfaces designed for comparable independence and ease of use.
- Manufacturers of affected devices would need to meet the standard or obtain a Secretary-approved waiver for "fundamental alteration" or "undue hardship." The agency must also provide training and consult the Architectural and Transportation Barriers Compliance Board and blind or low-vision individuals on the standard and compliance guidance.
- The bill makes devices that do not meet the standard or lack an approved waiver "adulterated" under section 501, giving the agency enforcement authority, and sets a rulemaking timetable that would require proposed regulations within 1 year and a final rule within 2 years.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
Accessible medical devices for blind and low-vision
If enacted, certain home-use Class II and III medical devices with screens or apps would need to work as well for blind or low-vision users as for sighted users. This would cover devices cleared or approved after the rule’s effective date, and not those meant only for providers or only outside the home. Starting then, covered devices that do not meet the standard would be treated as adulterated unless the Secretary grants a waiver. A waiver would require clear and convincing evidence that the rule would fundamentally change the device or cause an undue hardship for the maker.
Timeline and training for accessible medical devices
If enacted, the Secretary would propose rules within 1 year of enactment and issue a final rule within 2 years. The final rule would take effect 1 year after it is published. The Secretary would train device makers on the standard and how to comply. The Secretary would consult the federal accessibility board and people who are blind or have low vision while developing the rules and training.
Sponsors & CoSponsors
Sponsor
Schakowsky, Janice D. [D-IL-9]
IL • D
Cosponsors
Rep. Bacon, Don [R-NE-2]
NE • R
Sponsored 9/26/2025
Rep. Bishop, Sanford D. [D-GA-2]
GA • D
Sponsored 9/26/2025
Rep. Casten, Sean [D-IL-6]
IL • D
Sponsored 9/26/2025
Rep. Fitzpatrick, Brian K. [R-PA-1]
PA • R
Sponsored 9/26/2025
Rep. García, Jesús G. "Chuy" [D-IL-4]
IL • D
Sponsored 9/26/2025
Del. Norton, Eleanor Holmes [D-DC-At Large]
DC • D
Sponsored 9/26/2025
Rep. Panetta, Jimmy [D-CA-19]
CA • D
Sponsored 9/26/2025
Rep. Pocan, Mark [D-WI-2]
WI • D
Sponsored 9/26/2025
Rep. Quigley, Mike [D-IL-5]
IL • D
Sponsored 9/26/2025
Rep. Rutherford, John H. [R-FL-5]
FL • R
Sponsored 9/26/2025
Rep. Sessions, Pete [R-TX-17]
TX • R
Sponsored 9/26/2025
Rep. Smith, Adam [D-WA-9]
WA • D
Sponsored 9/26/2025
Rep. Hayes, Jahana [D-CT-5]
CT • D
Sponsored 10/6/2025
Rep. Craig, Angie [D-MN-2]
MN • D
Sponsored 10/6/2025
Rep. Lynch, Stephen F. [D-MA-8]
MA • D
Sponsored 10/6/2025
Rep. Tonko, Paul [D-NY-20]
NY • D
Sponsored 10/19/2026
Rep. Ross, Deborah K. [D-NC-2]
NC • D
Sponsored 3/16/2026
Rep. Walkinshaw, James R. [D-VA-11]
VA • D
Sponsored 3/27/2026
Rep. Doggett, Lloyd [D-TX-37]
TX • D
Sponsored 4/9/2026
Rep. McClellan, Jennifer L. [D-VA-4]
VA • D
Sponsored 4/9/2026
Rep. Frost, Maxwell [D-FL-10]
FL • D
Sponsored 4/20/2026
Rep. Raskin, Jamie [D-MD-8]
MD • D
Sponsored 4/20/2026
Rep. McBath, Lucy [D-GA-6]
GA • D
Sponsored 5/29/2026
Rep. Latimer, George [D-NY-16]
NY • D
Sponsored 6/9/2026
Rep. Auchincloss, Jake [D-MA-4]
MA • D
Sponsored 8/17/2026
Rep. McGovern, James P. [D-MA-2]
MA • D
Sponsored 8/24/2026
Rep. Simon, Lateefah [D-CA-12]
CA • D
Sponsored 8/31/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov