Medical Device Nonvisual Accessibility Act of 2025

Summary

Requires the Department of Health and Human Services to create and enforce a nonvisual accessibility standard for the user interfaces of many Class II and III medical devices used outside of clinical settings. The rulemaking must be proposed within 1 year, finalized within 2 years, and takes effect 1 year after publication; devices marketed after that effective date must meet the standard or obtain a waiver or be deemed adulterated if they do not.

• Directs HHS to create and enforce a nonvisual accessibility standard for user interfaces of many Class II and III medical devices used outside clinical settings.
• Requires a proposed rule within 1 year and a final rule within 2 years; the final rule becomes effective 1 year after publication.
• After the effective date, marketing a covered device that does not meet the standard (and lacks a waiver) is treated as adulteration under the FD&C Act.
• Covered devices are those cleared/authorized/approved after the rule's effective date and intended for use by lay users (not solely by health care providers).
• Includes consultation with the Access Board and people who are blind or low vision, plus required manufacturer training.
• Allows the Secretary to grant waivers if compliance would cause a fundamental alteration or undue hardship with clear and convincing evidence.
• Aims to improve privacy, independence, and safety for blind and low-vision users of in-home and other nonclinical medical devices.
• Focuses on compatibility with existing assistive technologies and encourages designing accessibility in from the start.
• Imposes new regulatory obligations on device manufacturers and creates an agency workload to develop, train, and enforce the standard.