H.R. 5605 — Medical Device Nonvisual Accessibility Act of 2025

This section sets forth 10 congressional findings concerning the inaccessibility of home medical devices (e.g., blood pressure monitors, sleep apnea machines, in-home chemotherapy treatments) to blind and low-vision individuals, the feasibility of nonvisual accessibility features (e.g., screen access technology), and the benefits of such features for all users.

This section establishes nonvisual accessibility standards under new section 515D of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for user interfaces of covered devices—defined as class II or III devices cleared under section 510(k), granted marketing authorization under section 513(f)(2), or approved under section 515 after the effective date; that have a user interface (i.e., a screen or mobile app); and not intended solely for use by health care providers or outside the home. The standard requires user interfaces to enable blind or low-vision individuals to access information, engage in interactions, and use services with effectiveness, privacy, independence, and ease comparable to sighted users (with waivers available for fundamental alterations to the device or undue hardships on manufacturers). It directs the Secretary of Health and Human Services, in consultation with the Architectural and Transportation Barriers Compliance Board and blind or low-vision individuals, to issue proposed regulations within one year of enactment and a final rule within two years (effective one year after publication) and to provide manufacturer training on compliance. This section further amends section 501 of the FD&C Act (21 U.S.C. 351) by adding paragraph (k) to deem covered devices adulterated, beginning on the section 515D(e) effective date, unless they meet the standard or receive a waiver. (Thus, the Food and Drug Administration may refuse entry, seize, or enjoin distribution of noncompliant devices, consistent with existing adulteration enforcement authorities.)