Medical Device Nonvisual Accessibility Act of 2025

Increased Independence and Privacy: The bill establishes a standard requiring that user interfaces allow blind or low-vision individuals to access information and engage in interactions with comparable privacy and independence as those without disabilities (Section 3(a)).

Improved Safety and Usability: By providing multiple methods to confirm readings and data, devices can become more user-sfriendly, which can lead to fewer mistakes and less waste (Section 2(8)).

Equitable Access to Home Care: The bill addresses the need for individuals to use medical devices designed for home use—such as blood pressure monitors, sleep apnea machines, and in-home chemotherapy treatments—in an equally effective and integrated manner (Section 2(4), Section 2(10)).

Inclusive Design Processes: The bill notes that designing devices to work with nonvisual access technology can be done at little or no extra cost if considered at the beginning of the design process (Section 2(9)).

Potential for Exemptions: The Secretary has the authority to waive the accessibility standards if a manufacturer provides clear and convincing evidence that following the standard would cause an undue hardship or a fundamental alteration to the product (Section 3(a)(b)).

Financial Burden Definitions: The bill defines "undue hardship" as an action requiring significant difficulty or expense, taking into account the cost of compliance and the manufacturer's financial resources (Section 3(a)(f)(3)).