# Medical Device Nonvisual Accessibility Act of 2023

This bill requires medical device manufacturers to make sure that blind and low-vision people can use their devices just as easily and independently as anyone else. Right now, many modern medical devices—like blood pressure monitors, sleep apnea machines, and home chemotherapy equipment—have digital screens and menus that only work if you can see them. This bill says that has to change.

The law applies to medical devices that are used at home and have digital interfaces, specifically those that are medium or high-risk devices approved by the FDA after the law takes effect. Manufacturers will need to design these devices so that blind or low-vision users can access all the same information and functions as sighted users, with the same level of privacy and independence. This could mean adding voice commands, audio feedback, tactile buttons, or compatibility with screen-reading software—whatever works best for the device. The bill recognizes that companies already use these kinds of accessibility features in phones and computers, so it's technically feasible.

The FDA will have about two years to write detailed rules explaining exactly how manufacturers need to meet this standard, and manufacturers will have another year after that to comply. The agency will also provide training to help device makers understand what they need to do. There are some exceptions: if making a device accessible would fundamentally change what it does or cause severe financial hardship for a small manufacturer, they can ask for a waiver. The bill also requires the FDA to work with disability advocates and accessibility experts when developing these rules, so the standards will be practical and actually useful for people who need them.

Medical Device Nonvisual Accessibility Act of 2023

Schakowsky, Janice D.

Medical Device Nonvisual Accessibility Act of 2023 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.