Medical Device Nonvisual Accessibility Act of 2025
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Overview
This bill, the Medical Device Nonvisual Accessibility Act of 2025, aims to improve the accessibility of medical devices for people who are blind or have low-vision. It requires the Food and Drug Administration (FDA) to establish standards for nonvisual accessibility in the user interfaces of certain medical devices, ensuring they are as usable as devices designed for people without disabilities. The bill also provides a process for manufacturers to request waivers if compliance would be overly burdensome and establishes a training program for manufacturers on these new accessibility standards.
Key provisions
- Establishes nonvisual accessibility standards for medical devices with digital interfaces.
- Defines ‘covered device’ as devices classified as II or III, cleared or approved by the FDA, with a user interface, and not solely for healthcare providers.
- Allows the FDA Secretary to grant waivers to manufacturers if compliance would cause a fundamental alteration to the device or undue hardship.
- Requires the FDA Secretary to conduct training for manufacturers on the new accessibility standards.
- Mandates consultation with the Architectural and Transportation Barriers Compliance Board (ATCB) in developing standards and training.
- Sets deadlines for proposed and final regulations regarding the accessibility standards.
- Defines key terms such as ‘fundamental alteration’ and ‘undue hardship’ related to compliance.
- Adds a new provision to Section 501 of the Federal Food, Drug, and Cosmetic Act regarding covered devices.
Bill text
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Sponsors
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27 on record
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