Medical Device Nonvisual Accessibility Act of 2024
Latest action · Jan 18, 2024 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedJan 18, 2024
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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.
Cosponsors 1
Members who signed on, in the order they did. All signed on Jan 18, 2024.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-IN | Mike Braun | Original | Jan 18, 2024 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| Senate | Health, Education, Labor, and Pensions Committee | Referred Jan 18, 2024 |
Actions 2
Everything that happened, newest first.
- Jan 18, 2024Introduced in Senate
- Jan 18, 2024Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 1328 | Medical Device Nonvisual Accessibility Act of 2023 | Related bill | Mar 10, 2023 |
Titles 2
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- A bill to amend the Federal Food, Drug, and Cosmetic Act to establish nonvisual accessibility standards for certain devices with digital interfaces, and for other purposes.
- Short Title(s) as Introduced
- Medical Device Nonvisual Accessibility Act of 2024
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Jan 18, 2024Introduced in Senate
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
