What does Preamble of HR 5605 do?

This bill proposes to amend the Federal Food, Drug, and Cosmetic Act. The amendment aims to establish nonvisual accessibility standards for devices with digital interfaces. The bill was introduced in the House of Representatives on September 26, 2025.

What does SHORT TITLE. of HR 5605 do?

This bill is formally titled the Medical Device Nonvisual Accessibility Act of 2025.

What does FINDINGS. of HR 5605 do?

This section outlines findings related to the accessibility of medical devices for blind or low-vision individuals. It notes that rapid advances in digital technology have created increasingly complex user interfaces, often relying solely on visual displays. The findings highlight that many home-use medical devices, such as blood pressure monitors and sleep apnea machines, lack nonvisual accessibility. The section asserts that inaccessible devices prevent blind or low-vision individuals from using them privately, independently, and safely. It acknowledges that screen access technology and other mechanisms can improve accessibility and that designing for compatibility early in the process can be cost-effective. The findings conclude that blind or low-vision consumers should be able to operate medical devices with equal effectiveness and ease of use as those without disabilities.

What does NONVISUAL ACCESSIBILITY STANDARDS FOR CERTAIN DEVICES. of HR 5605 do?

This section amends the Federal Food, Drug, and Cosmetic Act by inserting section 515D, establishing nonvisual accessibility standards for certain devices. The standard requires user interfaces of covered devices to be as effective for blind or low-vision individuals as they are for those without such vision, allowing comparable access, interaction, and privacy. The Secretary has the authority to waive these standards if application would cause a fundamental alteration to the product or undue hardship for the manufacturer. The Secretary is required to conduct training for manufacturers on these standards and consult with the Architectural and Transportation Barriers Compliance Board and individuals with visual impairments in developing them. The Secretary must issue proposed regulations within one year of enactment and a final rule within two years, with the final rule taking effect one year after publication. Covered devices are classified as Class II or III, cleared, authorized, or approved, have a user interface, and are not solely for healthcare provider use or outside the home. The term 'undue hardship' considers the cost of compliance and the manufacturer's financial resources.

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Medical Device Nonvisual Accessibility Act of 2025 — HR. 5605

Last updated: 9/26/2025 · Introduced: 9/26/2025

Author: Janice Schakowsky (D-IL)

TL;DR (AI)

This bill establishes nonvisual accessibility standards for certain medical devices with digital interfaces, requiring them to be as effective for blind or low-vision individuals as for those without vision impairments.
The bill directs the Secretary to develop and issue regulations for these standards, including training for manufacturers and consultation with accessibility experts.
Manufacturers may request waivers from the standards if compliance would cause undue hardship or fundamentally alter the product.

119th Congressin committeeOfficial page

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Includes provisions on preamble, short title., and 2 more.

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