I 
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 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 2021’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
(1) Rapid advances in digital technology have 
led to increasingly complex user interfaces for every-
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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, 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 incor-
porated 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 ef-
fective and widely available text-to-speech technology 
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may be sufficient to make such devices fully acces-
sible. 
(9) Devices that utilize these mechanisms will 
be more user-friendly in general by increasing meth-
ods for confirmation of readings, which has the po-
tential to lead to less waste and fewer mistakes. 
(10) 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. 
(11) 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 
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 acces-
sibility standards specified under section 515C.’’. 
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