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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3621 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  2d Session
                                S. 3621

    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 SENATE OF THE UNITED STATES

                            January 18, 2024

 Ms. Hassan (for herself and Mr. Braun) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 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 2024''.

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.--Section 501 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 351) is amended by adding at the end the 
following:
    ``(k)(1) Beginning on the effective date specified in section 
515D(d)(2), if it is a covered device, unless the device meets the 
nonvisual accessibility standard specified under section 515D or the 
Secretary issues a waiver with respect to the device under subparagraph 
(2).
    ``(2) The Secretary may waive the application of subparagraph (1) 
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 
subparagraph to the device would result in a fundamental alteration to 
the nature of the product or an undue hardship for the manufacturer.
    ``(3) In this paragraph:
            ``(A) The term `covered device' means a device that--
                    ``(i) is classified under section 513 into class II 
                or III;
                    ``(ii) 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 section 515D(d)(2);
                    ``(iii) has a user interface; and
                    ``(iv) is not intended solely for use by a health 
                care provider or in a setting outside the home.
            ``(B) 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.
            ``(C)(i) The term `undue hardship' means an action 
        requiring significant difficulty or expense, when considered in 
        light of the factors set forth in subclause (ii).
            ``(ii) In determining whether application of subparagraph 
        (1) would impose an undue hardship on a manufacturer of a 
        covered device, factors to be considered may include--
                    ``(I) the nature and cost of compliance with the 
                standard under section 515D; and
                    ``(II) the overall financial resources of the 
                manufacturer of a covered device.
            ``(D) 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) Recognition of Standard.--The Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 515C (21 U.S.C. 360e-4) 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 the same 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) 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.
    ``(c) Stakeholders.--In developing the standard under subsection 
(a) and the training to be conducted under subsection (b), the 
Secretary shall consult with--
            ``(1) the Architectural and Transportation Barriers 
        Compliance Board established under section 502 of the 
        Rehabilitation Act of 1973; and
            ``(2) individuals who are blind or who have low-vision.
    ``(d) Regulations.--
            ``(1) In general.--The Secretary shall, in consultation 
        with the Architectural and Transportation Barriers Compliance 
        Board referred to in subsection (c)(1)--
                    ``(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.''.
                                 <all>
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