Title: Medical Device Nonvisual Accessibility Act of 2021
Policy area: Health

Summary:
Medical Device Nonvisual Accessibility Act of 2021
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.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4853 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 4853

    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

                             July 29, 2021

Ms. Schakowsky 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 2021''.

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, and in-home chemotherapy treatments generally lack 
        nonvisual accessibility.
            (5) If a medical device is not accessible in a nonvisual 
        manner, a blind or low-vision individual cannot use it safely.
            (6) Many technology companies have incorporated screen 
        access technology functions 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) Tactile markings, audible tones, or cost effective and 
        widely available text-to-speech technology may be sufficient to 
        make such devices fully accessible.
            (9) Devices that utilize these mechanisms will be more 
        user-friendly in general by increasing methods for confirmation 
        of readings, which has the potential to lead to less waste and 
        fewer mistakes.
            (10) 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.
            (11) 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 inserting after subsection 
(j) the following:
    ``(k) If it is a device classified under section 513 into class II 
or III, unless the device meets the nonvisual accessibility standards 
specified under section 515C.''.
    (b) Recognition of Standard.--The Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 515B (21 U.S.C. 360e-3) the 
following:

``SEC. 515C. NONVISUAL ACCESSIBILITY STANDARDS FOR CERTAIN DEVICES.

    ``(a) Standard.--The nonvisual accessibility standard specified in 
this section is, with respect to a digital interface of a device 
described in section 501(k), that the digital interface allows for 
blind or low-vision individuals to access the same information, engage 
in the same interactions, and to enjoy the same services with the same 
privacy, independence, and ease of use offered to individuals who do 
not have low-vision or are not blind.
    ``(b) Training.--The Secretary shall, in consultation with the 
Architectural and Transportation Barriers Compliance Board (established 
under section 504 of the Rehabilitation Act of 1973), conduct training 
to educate manufacturers of a digital interface of a device described 
in section 501(k) or of a device described in such section on the 
standards developed under subsection (a).
    ``(c) Regulations.--The Secretary shall, in consultation with the 
Architectural and Transportation Barriers Compliance Board--
            ``(1) 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
            ``(2) not later than 2 years after the date of the 
        enactment of this section, publish a final rule with respect to 
        such proposed regulations.
    ``(d) Effective Date.--A final rule published under subsection 
(c)(2) shall take effect 1 year after the publication of such rule.
    ``(e) Digital Interface Defined.--In this section, the term 
`digital interface' means a means by which human users interact or 
communicate with electronic devices, including computerized devices.
    ``(f) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $1,500,000 fiscal years 2023 
through 2024.''.
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