Bill would require home medical devices to work for blind users

What does this do?

HR 5605 would require home-use medical devices in FDA Class II and III that have a screen or app interface to be equally usable by people who are blind or have low vision. Accessibility features such as text-to-speech or other non-visual methods would be required. The FDA would have one year to propose rules, two years to finalize them, and manufacturers would need to comply one year after the final rules are published.

Who does it affect?

The bill directly affects people who are blind or have low vision and use home medical devices such as blood pressure monitors, sleep apnea machines, and home chemotherapy equipment. It also affects the manufacturers of those devices, who would be required to build accessibility into products from the design stage.

Why does it matter?

Patients who are blind or have low vision would gain the ability to use their own medical equipment privately and independently. Manufacturers would face new design requirements and the option to apply for a waiver if compliance would fundamentally change how a device works or create a serious financial burden, particularly for smaller companies.

What does it cost, and who pays?

• Little or no added cost if planned early
• Waivers available for serious financial burden
• Smaller companies specifically mentioned

Where does it stand?