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Medical Device Nonvisual Accessibility Act of 2024
2/3/2024, 12:45 PM
Summary of Bill S 3621
The bill requires manufacturers of medical devices to make their products accessible to individuals with visual impairments. This includes ensuring that devices have nonvisual accessibility features, such as audible or tactile feedback, that allow individuals to use the devices effectively.
Additionally, the bill 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 2024 aims to improve access to medical devices for individuals who are blind or visually impaired, ensuring that they can effectively use these devices to manage their health and well-being.
Congressional Summary of S 3621
Medical Device Nonvisual Accessibility Act of 2024
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. However, the FDA may waive the bill's requirements for a device upon a showing that applying the standards would fundamentally alter the nature of the device or create an undue hardship for the manufacturer. The bill also does not apply to devices that are intended solely for use by a health care provider or in a setting outside the home.
