0
Medical Device Nonvisual Accessibility Act of 2021
12/31/2022, 5:04 AM
Summary of Bill HR 4853
Specifically, the bill mandates that medical devices must have nonvisual accessibility features, such as audible output or tactile input, to allow individuals with visual impairments to use the devices effectively. This includes features such as speech output, braille labels, and tactile buttons.
The bill also requires manufacturers to provide documentation in accessible formats, such as braille or large print, to ensure that individuals with visual impairments can understand how to use the devices properly. Overall, the Medical Device Nonvisual Accessibility Act of 2021 seeks to promote inclusivity and accessibility in the healthcare industry by ensuring that individuals with visual impairments have equal access to medical devices.
Congressional Summary of HR 4853
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.
