119-hr5605

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5605 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 5605

 To amend the Federal Food, Drug, and Cosmetic Act to establish 
 nonvisual accessibility standards for certain devices with digital 
 interfaces, and for other purposes.

_______________________________________________________________________

 IN THE HOUSE OF REPRESENTATIVES

 September 26, 2025

 Ms. Schakowsky (for herself, Mr. Bacon, Mr. Bishop, Mr. Casten, Mr. 
 Fitzpatrick, Mr. Garcia of Illinois, Ms. Norton, Mr. Panetta, Mr. 
 Pocan, Mr. Quigley, Mr. Rutherford, Mr. Sessions, and Mr. Smith of 
 Washington) introduced the following bill; which was referred to the 
 Committee on Energy and Commerce

_______________________________________________________________________

 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.

 Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

 This Act may be cited as the ``Medical Device Nonvisual 
Accessibility Act of 2025''.

SEC. 2. FINDINGS.

 Congress finds the following:

    (1) Rapid advances in digital technology have led to 
 increasingly complex user interfaces for everyday products, 
 such as life-sustaining medical devices and technologies.

    (2) Many of these new devices utilize displays that can 
 only be operated visually and require user interaction with on-
 screen menus and other interfaces that are inaccessible to 
 consumers who are blind or have low-vision.

    (3) Medical devices designed for use in the home are being 
 increasingly utilized to lessen the cost of inpatient care for 
 consumers.

    (4) Devices such as blood pressure monitors, sleep apnea 
 machines, in-home chemotherapy treatments, and many others 
 generally lack nonvisual accessibility.

    (5) If a medical device is not accessible in a nonvisual 
 manner, a blind or low-vision individual is unable to use it 
 privately, independently, and safely.

    (6) Many technology companies have incorporated screen 
 access technology functions, such as text to speech software, 
 into products developed and sold by such companies.

    (7) Screen access technology is not the only mechanism by 
 which medical devices can be made accessible to blind or low-
 vision consumers.

    (8) Devices that utilize these mechanisms will be more 
 user-friendly in general by including multiple methods to 
 confirm readings and other data, leading to less waste and 
 fewer mistakes.

    (9) Devices can be designed to work with nonvisual access 
 technology used by individuals who are blind or have low-vision 
 at little or no extra cost as long as such compatibility is 
 taken into consideration at the beginning of the design 
 process.

    (10) Consumers who are blind or have low-vision must be 
 able to operate medical devices in an equally effective and 
 equally integrated manner and with equivalent ease of use as 
 consumers without disabilities.

SEC. 3. NONVISUAL ACCESSIBILITY STANDARDS FOR CERTAIN DEVICES.

    (a) In General.--The Federal Food, Drug, and Cosmetic Act is 
amended by inserting after 

section 515C (as added by Public Law 117-
328) the following:

``

SEC. 515D. NONVISUAL ACCESSIBILITY STANDARDS FOR CERTAIN DEVICES.

 ``

    (a) Standard.--The nonvisual accessibility standard specified in 
this section is, with respect to a user interface of a device described 
in 

section 501

    (k) , that the user interface is 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.
 ``

    (b) Waiver.--The Secretary may waive the application of 

section 501

    (k) with respect to a covered device if, based on clear and 
convincing evidence (as determined by the Secretary) provided by the 
manufacturer involved, the Secretary determines that the application of 
such section to the device would result in a fundamental alteration to 
the nature of the product or an undue hardship for the manufacturer.
 ``
            (c) Training.--The Secretary shall conduct training to educate 
manufacturers of a user interface of a device described in 

section 501

    (k) or of a device described in such section on the standards 
developed under subsection

    (a) and how to comply with such standard.
 ``
            (d) Stakeholders.--In developing the standard under subsection

    (a) and the training to be conducted under subsection
            (c) , the 
Secretary shall consult with--
 ``

    (1) the Architectural and Transportation Barriers 
 Compliance Board established under 

section 504 of the 
 Rehabilitation Act of 1973; and
 ``

    (2) individuals who are blind or who have low-vision.
 ``

    (e) Regulations.--
 ``

    (1) In general.--The Secretary shall, in consultation 
 with the Architectural and Transportation Barriers Compliance 
 Board referred to in subsection
            (d) --
 ``
        (A) not later than 1 year after the date of the 
 enactment of this section, issue proposed regulations 
 to implement the standard specified under subsection

    (a) ; and
 ``
        (B) not later than 2 years after the date of the 
 enactment of this section, publish a final rule with 
 respect to such proposed regulations.
 ``

    (2) Effective date.--The final rule published under 
 paragraph

    (1)
        (B) shall take effect on the date that is 1 year 
 after the date on which such rule is published.
 ``

    (f) 

=== Definitions. ===
-In this section:
 ``

    (1) The term `covered device' means a device that--
 ``
        (A) is classified under 

section 513 into class II 
 or III;
 ``
        (B) is cleared under 

section 510

    (k) , granted 
 marketing authorization under 

section 513

    (f)

    (2) , or 
 approved under 

section 515 after the effective date 
 specified in subsection

    (e) ;
 ``
            (C) has a user interface; and
 ``
            (D) is not intended solely for use by a health 
 care provider or in a setting outside the home.
 ``

    (2) The term `fundamental alteration' means an alteration 
 to the nature of a covered device that would render it unusable 
 or incapable of performing an essential function.
 ``

    (3)
        (A) The term `undue hardship' means an action 
 requiring significant difficulty or expense, when considered in 
 light of the factors specified in subparagraph
        (B) .
 ``
        (B) In determining whether application of this section 
 would impose an undue hardship on a manufacturer of a covered 
 device, factors to be considered may include
 ``
            (C) the nature and cost of compliance with the 
 standard under this section; and
 ``
            (D) the overall financial resources of the 
 manufacturer of a covered device.
 ``

    (4) The term `user interface' means a screen or mobile 
 application through which a human user interacts or 
 communicates with the device by inputting or receiving 
 information.''.

    (b) Adulteration.--

Section 501 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 351) is amended by inserting after paragraph

    (j) the following:
 ``

    (k) Beginning on the effective date specified in subsection

    (e) of 

section 515D, if it is a covered device (as defined in such 
section), unless the device meets the nonvisual accessibility standard 
specified under such section or the Secretary issues a waiver with 
respect to the device under such section.''.
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