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)]
<DOC>
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.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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