I 
118TH CONGRESS 
1ST SESSION H. R. 1328 
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 
MARCH 1, 2023 
Ms. SCHAKOWSKY (for herself, Mr. TRONE, Mr. VEASEY, Mr. BISHOP of Geor-
gia, Mr. PANETTA, Mr. SARBANES, Mr. POCAN, Mr. QUIGLEY, Mr. 
SMITH of Washington, Mr. RUPPERSBERGER, Ms. BUSH, Mr. SESSIONS, 
Mr. LARSON of Connecticut, Ms. LEE of California, Mr. GRIJALVA, Mr. 
CASTEN, Mr. GARCI´A of Illinois, Mr. RUTHERFORD, Mr. LYNCH, Ms. 
TITUS, Ms. BLUNT ROCHESTER, Mrs. CHERFILUS-MCCORMICK, Mr. 
CONNOLLY, Mr. CASE, Mr. KEATING, Mr. FITZPATRICK, Mr. DAVIS of 
Illinois, Ms. TLAIB, Ms. CRAIG, Ms. SEWELL, Mrs. HAYES, Mr. KILDEE, 
and Ms. KUSTER) 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 de-
vices with digital interfaces, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medical Device Non-
visual Accessibility Act of 2023’’. 
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SEC. 2. FINDINGS. 
Congress finds the following: 
(1) Rapid advances in digital technology have 
led to increasingly complex user interfaces for every-
day 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 inter-
faces 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 treat-
ments, and many others generally lack nonvisual ac-
cessibility. 
(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 incor-
porated screen access technology functions, such as 
text to speech software, into products developed and 
sold by such companies. 
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(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 mul-
tiple methods to confirm readings and other data, 
leading to less waste and fewer mistakes. 
(9) Devices can be designed to work with non-
visual 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 consider-
ation at the beginning of the design process. 
(10) Consumers who are blind or have low-vi-
sion 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 CER-
TAIN 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), if it is a covered device, unless the device 
meets the nonvisual accessibility standard specified under 
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section 515D or the Secretary issues a waiver with respect 
to the device under subparagraph (2). 
‘‘(2) The Secretary may waive the application of sub-
paragraph (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 subpara-
graph to the device would result in a fundamental alter-
ation 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); 
‘‘(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 
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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 
clause (ii). 
‘‘(ii) In determining whether application of this 
subparagraph would impose an undue hardship on a 
manufacturer of a covered device, factors to be con-
sidered 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 (as added by Public Law 117–328) the 
following: 
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‘‘SEC. 515D. NONVISUAL ACCESSIBILITY STANDARDS FOR 
CERTAIN DEVICES. 
‘‘(a) STANDARD.—The nonvisual accessibility stand-
ard specified in this section is, with respect to a user inter-
face of a device described in section 501(k), that the user 
interface is as effective in allowing blind or low-vision indi-
viduals 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 indi-
viduals who do not have low-vision or are not blind. 
‘‘(b) TRAINING.—The Secretary shall conduct train-
ing to educate manufacturers of a user interface of a de-
vice described in section 501(k) or of a device described 
in such section on the standards developed under sub-
section (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 Bar-
riers Compliance Board established under section 
504 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 con-
sultation with the Architectural and Transportation 
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Barriers Compliance Board referred to in subsection 
(b)— 
‘‘(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 pub-
lished under paragraph (1)(B) shall take effect on 
the date that is 1 year after the date on which such 
rule is published. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section 
$1,500,000 the period of fiscal years 2024 through 
2025.’’. 
Æ 
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