No official summary available for this bill.
[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.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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