Medical Device Nonvisual Accessibility Act of 2025

This bill requires home medical devices like blood pressure monitors and sleep apnea machines to include nonvisual accessibility features (such as screen readers or audio feedback) so blind or low-vision users can operate them independently and safely. It sets a standard that devices must be as effective for these users as for sighted individuals, applying to Class II/III devices cleared under FDA's 510(k) process for home use. The FDA must issue proposed regulations within one year and final rules within two years of enactment, with manufacturers needing to comply one year after the final rule takes effect. Devices may qualify for waivers only if compliance would cause a "fundamental alteration" or "undue hardship" for the manufacturer, though the bill emphasizes accessibility can often be integrated without extra cost during design.