This bill would amend the Federal Food, Drug, and Cosmetic Act to set nonvisual accessibility standards for certain medical devices with digital user interfaces. The standard applies to covered devices that are class II or III and that receive 510(k) clearance, certain marketing authorizations, or approvals after the rule takes effect, that have a user interface, and that are not intended only for health care providers or for use outside the home. The Secretary must develop the accessibility standard, consult with the Architectural and Transportation Barriers Compliance Board and individuals who are blind or have low vision, provide training for manufacturers, and issue proposed regulations within 1 year and a final rule within 2 years (the final rule takes effect 1 year after publication). Manufacturers may request a waiver if meeting the standard would cause a fundamental alteration or undue hardship, and devices that are covered but do not meet the standard would be treated as adulterated under section 501.
No publicly available information. The bill text does not include cost estimates, funding, or detailed economic analysis. The waiver provisions allow the Secretary to consider the nature and cost of compliance and a manufacturer's financial resources when deciding undue hardship.
The bill states that many modern medical device interfaces are visual-only and can be inaccessible to people who are blind or have low vision. Proponents say that designing nonvisual access (such as text-to-speech, audio, tactile features, or compatibility with existing assistive technologies) early in development can be done at little or no extra cost, will allow private and independent use, and can improve general usability and reduce errors.
No publicly available information on opposition in the bill text. The bill does include a waiver process for cases of fundamental alteration or undue hardship, which acknowledges potential burdens on some manufacturers.