Medical Device Nonvisual Accessibility Act of 2025
- Sponsor
- Rep. Schakowsky, Janice D. [D-IL-9]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- Sep 26, 2025
Bottom line
The bill aims to enhance the independence and safety of blind and low-vision individuals by requiring home-use medical devices with digital interfaces to meet nonvisual accessibility standards.
What it actually does
This bill amends the Federal Food, Drug, and Cosmetic Act to establish nonvisual accessibility standards for certain medical devices with digital interfaces. It mandates the Food and Drug Administration (FDA) to develop regulations and training to ensure that blind or low-vision individuals can use these devices with comparable privacy, independence, and ease of use as sighted individuals. The bill also provides for waivers in cases of fundamental alteration or undue hardship for manufacturers.
Proponents argue
Proponents argue that as medical devices increasingly rely on digital interfaces for in-home use, it is crucial to ensure they are accessible to all, preventing discrimination and promoting health equity. They emphasize that early design consideration for accessibility can be low-cost and improve usability for everyone, making devices safer and more effective for a wider population.
Opponents contend
Potential opponents might argue that implementing new accessibility standards could impose significant costs and administrative burdens on medical device manufacturers, potentially slowing innovation or increasing device prices, especially for smaller companies. They might also raise concerns about the technical feasibility of achieving 'comparable' accessibility for all device types without fundamentally altering their function.
The bill is concise and can be read quickly, allowing ample time for evaluation of its provisions.
Section 3(a), inserting new Section 515D(a) into the Federal Food, Drug, and Cosmetic Act.
Nonvisual Accessibility Standard for Covered Devices
This provision establishes a new standard requiring that the user interface of certain medical devices must be as effective for blind or low-vision individuals to access information, interact, and use services with comparable privacy, independence, and ease of use as it is for individuals without vision impairments. This ensures equitable access to essential medical technologies.
Supporters argue
Supporters argue this standard is essential to ensure equitable access to modern medical technology, preventing a growing disparity as more devices rely on visual interfaces. They contend that accessibility is a fundamental right and that early design integration can minimize costs.
Critics contend
Opponents might argue that a broad standard could be difficult to apply uniformly across diverse medical devices, potentially stifling innovation or imposing disproportionate costs on manufacturers, especially for specialized or low-volume devices.
Tradeoffs
This provision balances the right to accessibility for individuals with disabilities against potential compliance burdens and costs for medical device manufacturers.
Section 3(a), inserting new Section 515D(b) into the Federal Food, Drug, and Cosmetic Act.
Waiver for Fundamental Alteration or Undue Hardship
This provision allows the Secretary of the FDA to waive the accessibility standard for a covered device if a manufacturer provides clear and convincing evidence that applying the standard would fundamentally alter the product's nature or impose an undue hardship. 'Fundamental alteration' means rendering the device unusable, while 'undue hardship' considers the nature, cost of compliance, and overall financial resources of the manufacturer.
Section 3(a), inserting new Section 515D(c) and (d) into the Federal Food, Drug, and Cosmetic Act.
FDA Training and Stakeholder Consultation for Standard Development
This provision mandates the Secretary of the FDA to conduct training for manufacturers on how to comply with the new nonvisual accessibility standards. It also requires the Secretary to consult with the Architectural and Transportation Barriers Compliance Board and individuals who are blind or have low-vision when developing both the standard and the training programs.
Section 3(a), inserting new Section 515D(e) into the Federal Food, Drug, and Cosmetic Act.
Timeline for Regulations and Implementation
This provision sets a timeline for the FDA to issue proposed regulations within one year of the bill's enactment and a final rule within two years. The final rule will take effect one year after its publication. This establishes a clear schedule for the development and implementation of the nonvisual accessibility standards.
Section 3(a), inserting new Section 515D(f)(1) into the Federal Food, Drug, and Cosmetic Act.
Scope of Devices Subject to Standards
This provision defines a 'covered device' as a device classified under section 513 into class II or III, cleared or approved after the effective date of the regulations, has a user interface, and is not intended solely for use by a healthcare provider or in a setting outside the home. This limits the scope to consumer-facing, higher-risk medical devices used in home settings.
Section 3(b), amending Section 501 of the Federal Food, Drug, and Cosmetic Act.
Non-Compliant Devices Deemed Adulterated
This provision states that, beginning on the effective date of the new regulations, any 'covered device' that does not meet the nonvisual accessibility standard (or for which a waiver has not been issued) will be considered 'adulterated' under the Federal Food, Drug, and Cosmetic Act. This means such devices cannot be legally marketed or sold.
Defines 'user interface' as 'a screen or mobile application through which a human user interacts or communicates with the device by inputting or receiving information.'
Section 3(a), inserting new Section 515D(f)(4) into the Federal Food, Drug, and Cosmetic Act.
Why it matters:This is standard legislative practice to place definitions at the end of a section to provide clarity for the preceding provisions.
Case for: This definition is crucial for clarity, ensuring the accessibility standards apply specifically to digital interaction points, which are the primary source of inaccessibility for blind and low-vision users. It prevents overreach to purely mechanical devices.
Case against: Some might argue this definition is too narrow, potentially excluding devices with non-screen-based digital interactions (e.g., touchpads without visual feedback, voice-only interfaces that are poorly designed) that could still pose accessibility challenges.
Estimated impact: Clarifies the scope of the bill, focusing its impact on devices with visual screens or mobile app controls, thereby managing the regulatory burden.
The standard requires the user interface to be 'as effective in allowing blind or low-vision individuals to access information, engage in interactions, and enjoy services with comparable privacy, independence, and ease of use as the user interface of the device enables individuals who do not have low-vision or are not blind.'
Section 3(a), inserting new Section 515D(a) into the Federal Food, Drug, and Cosmetic Act.
Why it matters:This is the precise legal language for the standard, which is necessarily detailed to ensure enforceability and comprehensive coverage of accessibility aspects.
Case for: This wording sets a high bar for accessibility, ensuring that solutions are not merely functional but truly comparable to the experience of sighted users, covering aspects like privacy and independence which are crucial for medical device use, especially in personal health management.
Case against: Some manufacturers might argue that 'comparable privacy, independence, and ease of use' is a subjective and potentially difficult standard to measure and achieve across all device types, leading to ambiguity in compliance and potential legal disputes.
Estimated impact: Shapes the rigor and quality of accessibility solutions required from manufacturers, influencing the design philosophy and user experience of future medical devices.