Sponsors (24)
The bill substantially improves privacy, independence, and safety for people who are blind or have low vision using home medical devices, at the trade-off of higher manufacturer and regulatory costs that could raise prices or delay some devices' market entry.
People who are blind or have low vision gain private, independent access to home medical device interfaces through required nonvisual access features.
Patients with chronic conditions and seniors can more independently manage care and face fewer errors or wasted supplies because accessible nonvisual interfaces provide additional confirmation methods and clearer interaction.
Clearer regulatory timelines and training for manufacturers reduce uncertainty about accessibility requirements, helping organizations and health systems plan for compliance.
Manufacturers may incur additional design and testing costs to meet nonvisual accessibility requirements, which could raise device prices for consumers and taxpayers.
Devices that cannot be feasibly modified or require substantial redesign may face delayed market entry or manufacturers may seek waivers, slowing patient access to new home medical technologies.
Mandating additional interface options and implementing these rules will require FDA staffing, training, consultations, and waiver reviews, increasing regulatory complexity and administrative burden.
Based on analysis of 3 sections of legislative text.
Requires FDA to set and enforce nonvisual accessibility standards for user interfaces on many Class II and III medical devices, with a defined rulemaking timeline and limited waiver authority.
Official title: To amend the Federal Food, Drug, and Cosmetic Act to establish nonvisual accessibility standards for certain devices with digital interfaces, and for other purposes.
Introduced September 26, 2025 by Janice D. Schakowsky · Last progress September 26, 2025
Requires the FDA to write and implement a nonvisual accessibility standard for certain medical device user interfaces so blind and low-vision people can use them as effectively and independently as sighted users. The bill covers many Class II and III devices with user interfaces (excluding provider-only or out-of-home devices), sets rulemaking and consultation deadlines, allows limited waivers, and phases applicability to devices cleared or approved after the rule’s effective date.