Medical Device Nonvisual Accessibility Act of 2021
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Medical Device Nonvisual Accessibility Act of 2021
This bill requires certain medical devices with a digital interface to meet nonvisual accessibility standards established by the Food and Drug Administration (FDA).
Specifically, the FDA must establish regulations to require a Class II or Class III medical device with a digital interface to provide a blind or low-vision user access to the same services and information, and generally the same ease of use, as provided to a user who is not low-vision or blind. (The FDA classifies medical devices in three classes. Class I devices are low-risk, Class II devices are moderate-risk, and Class III devices are high-risk.)
A Class II or Class III medical device that does not meet the nonvisual accessibility standards established under this bill may not be sold.
Referred to the Subcommittee on Health.
- Introduced in House Formatted Text PDF Formatted XML
Cite this page
U.S. Congress. (2026). H.R. 4853: Medical Device Nonvisual Accessibility Act of 2021. 117th Congress. Open America. https://openamerica.io/bill/117-HR-4853/
"H.R. 4853: Medical Device Nonvisual Accessibility Act of 2021." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-HR-4853/.
H.R. 4853, 117th Cong. (2026), https://openamerica.io/bill/117-HR-4853/.
[H.R. 4853: Medical Device Nonvisual Accessibility Act of 2021](https://openamerica.io/bill/117-HR-4853/)