This bill, titled the Medical Device Nonvisual Accessibility Act of 2025, aims to amend the Federal Food, Drug, and Cosmetic Act by establishing new nonvisual accessibility standards for certain medical devices. It addresses the growing concern that many modern medical devices, particularly those intended for home use, feature digital interfaces that are inaccessible to individuals who are blind or have low vision. The legislation seeks to ensure that these devices can be operated with comparable privacy, independence, and ease of use by all consumers. The bill mandates that the user interface of a covered device must be as effective for blind or low-vision individuals as it is for sighted users in accessing information and engaging with services. A "covered device" is defined as a Class II or III device with a user interface, cleared or approved after the effective date, and not solely for professional or institutional use. The Secretary of Health and Human Services is tasked with developing these standards and providing training to manufacturers on compliance. Manufacturers may seek a waiver from these standards if compliance would result in a fundamental alteration to the product's nature or an undue hardship , based on clear and convincing evidence. The Secretary must consult with accessibility experts and blind or low-vision individuals in developing the standards and training. Non-compliant covered devices will be deemed adulterated under the Federal Food, Drug, and Cosmetic Act, ensuring enforcement of these new accessibility requirements. The Secretary must issue proposed regulations within one year and a final rule within two years, with the rule taking effect one year after publication.