Sponsors (22)
The bill improves independence and safety for people with visual impairments by requiring accessible home medical device interfaces, but it imposes design, compliance, and administrative costs that can raise prices, delay some product availability, and strain smaller manufacturers.
People who are blind or have low vision gain substantially improved access to home medical device controls and information, enabling more independent, private use of their devices.
Patients (including those with chronic conditions) experience safer, more reliable self-management because accessible interfaces reduce user errors, provide multiple confirmation methods, and make device information easier to perceive.
Manufacturers and the health ecosystem benefit from clearer regulatory timelines, training, and consistent accessibility expectations, which reduce compliance uncertainty and promote more uniform accessibility across new devices.
Manufacturers will likely incur design, testing, and compliance costs to meet accessibility requirements, which could raise device development expenses and contribute to higher prices for consumers or greater costs for taxpayers if supported by enforcement.
Regulatory requirements and redesign needs could delay market entry for some devices, reducing short-term availability of new home-use medical technologies and potentially limiting options for patients and providers.
Smaller manufacturers may struggle with meeting compliance deadlines or proving undue hardship, putting them at a competitive disadvantage relative to larger firms and potentially reducing market competition.
Based on analysis of 3 sections of legislative text.
Requires HHS to set nonvisual accessibility standards for user interfaces of certain Class II and III medical devices and deems noncompliant covered devices adulterated unless waived.
Introduced September 26, 2025 by Janice D. Schakowsky · Last progress September 26, 2025
Requires the Department of Health and Human Services to create and enforce standards that make the user interfaces of many Class II and III medical devices nonvisually accessible for people who are blind or have low vision. The agency must propose rules within 1 year, finalize them within 2 years, and the final rule becomes effective one year after publication; devices cleared, granted, or approved after that effective date must meet the standards or receive a waiver, or they are treated as adulterated. The law directs HHS to consult accessibility experts and blind/low‑vision individuals, provide manufacturer compliance training, and allow waivers where meeting the standard would cause a fundamental alteration or undue hardship.