HR5605-119

What This Bill Does

The Medical Device Nonvisual Accessibility Act of 2025 addresses home-use medical devices that rely on visual user interfaces. The findings explain that blood pressure monitors, sleep apnea machines, in-home chemotherapy treatments, and other home medical devices often lack nonvisual accessibility, which can prevent blind or low-vision people from using them privately, independently, and safely. The operative section adds FDA nonvisual accessibility standards for covered class II and III devices that are cleared, authorized, or approved after the effective date, have a user interface, and are not intended solely for provider use or outside-the-home settings. The standard requires the device interface to allow blind or low-vision users to access information, interact, and use services with comparable privacy, independence, and ease of use. FDA may waive the requirement based on clear and convincing evidence that applying it would fundamentally alter the product or impose undue hardship. FDA must train manufacturers, consult the Access Board and blind or low-vision individuals, issue proposed regulations within one year, publish a final rule within two years, and make the final rule effective one year after publication.

Who Benefits and How

Blind medical device users benefit because covered home-use devices must provide comparably effective nonvisual access. Low-vision patients benefit because user interfaces must support privacy, independence, and ease of use similar to sighted users. Disability rights organizations benefit from required FDA consultation with blind and low-vision individuals and the Access Board. Accessible technology developers benefit if device makers need screen access, tactile, audio, or other nonvisual interface solutions.

Who Bears the Burden and How

Medical device manufacturers must design covered class II and III home-use devices to meet nonvisual accessibility standards unless waived. FDA medical device staff must write regulations, evaluate waivers, train manufacturers, and consult disability-access experts. Access Board staff must consult with FDA on standards and training. Manufacturers seeking waivers must provide clear and convincing evidence of fundamental alteration or undue hardship.

Key Provisions

• Requires FDA nonvisual accessibility standards for covered class II and III home-use medical devices with user interfaces.
• Provides comparable privacy, independence, and ease-of-use access for blind and low-vision users.
• Authorizes waivers for fundamental alteration or undue hardship based on clear and convincing evidence.
• Requires manufacturer training and consultation with the Access Board and blind or low-vision individuals.
• Requires proposed regulations within one year, a final rule within two years, and effectiveness one year after the final rule.