H.R. 5605 requires medical device manufacturers to make devices with digital interfaces accessible to people who are blind or have low vision. The bill applies to certain home-use medical devices—such as blood pressure monitors and sleep apnea machines—that are classified as moderate or high-risk by the FDA and are cleared or approved after the law takes effect. Manufacturers must ensure their devices' user interfaces provide blind and low-vision users with comparable access, privacy, and ease of use as sighted users, though the FDA can grant waivers if compliance would fundamentally alter the product or create undue hardship. The FDA has one year from enactment to propose regulations and two years to issue final rules, which take effect one year later, with the FDA required to train manufacturers and consult with disability advocates during the process.
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