Bill > HR5605

This bill aims to improve accessibility for individuals who are blind or have low vision by establishing nonvisual accessibility standards for certain medical devices used in home settings. The legislation would require medical devices with digital interfaces to be designed in a way that allows blind or low-vision users to access information and interact with the device with the same level of privacy, independence, and ease of use as sighted users. The bill mandates that the Food and Drug Administration (FDA) develop specific standards for these devices, focusing on class II and III medical devices with user interfaces intended for home use, such as blood pressure monitors and sleep apnea machines. Manufacturers would be required to incorporate nonvisual accessibility features, though they could request a waiver if implementing the standards would fundamentally alter the device or cause undue financial hardship. The FDA would be responsible for creating proposed regulations within one year and final rules within two years, with implementation beginning one year after the final rule is published. The bill also requires the FDA to consult with accessibility experts and individuals who are blind or have low vision during the standards development process, with the ultimate goal of ensuring that people with visual impairments can safely and independently use medical devices in their homes.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/5605/all-info