What This Bill Does
This bill amends federal law to require certain medical devices with digital interfaces to be accessible to people who are blind or have low vision. The law would establish standards that medical device makers must follow to ensure blind and low-vision users can operate devices safely and independently, using the same methods and ease as people without vision disabilities.
Who It Affects
Manufacturers of medical devices with digital screens or mobile applications. People who are blind or have low vision. The U.S. Food and Drug Administration (FDA). The Architectural and Transportation Barriers Compliance Board (an independent agency that sets accessibility standards).
Key Provisions
• Medical devices classified as Class II or III that are cleared or approved after an
What Changes
If this becomes law, medical device makers will be required to design new Class II and Class III devices so that blind and low-vision users can access information, interact with the device, and use services with the same privacy, independence and ease of use as other users. Devices that fail to meet these standards could be blocked from the market unless manufacturers receive a waiver. The FDA would gain new responsibilities to create accessibility guidelines and educate manufacturers.
Important Definitions
"Covered device" means a Class II or Class III medical device with a user interface that is cleared or approved after the
Effective Date
The law takes effect one year after the FDA publishes its final regulations. The FDA must issue proposed regulations no later than one year after the law passes and publish final rules no later than two years after the law passes.
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-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Medical Device Non-
4
visual Accessibility Act of 2023’’.
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•HR 1328 IH
SEC. 2. FINDINGS.
1
Congress finds the following:
2
(1) Rapid advances in digital technology have
3
led to increasingly complex user interfaces for every-
4
day products, such as life-sustaining medical devices
5
and technologies.
6
(2) Many of these new devices utilize displays
7
that can only be operated visually and require user
8
interaction with on-screen menus and other inter-
9
faces that are inaccessible to consumers who are
10
blind or have low-vision.
11
(3) Medical devices designed for use in the
12
home are being increasingly utilized to lessen the
13
cost of inpatient care for consumers.
14
(4) Devices such as blood pressure monitors,
15
sleep apnea machines, in-home chemotherapy treat-
16
ments, and many others generally lack nonvisual ac-
17
cessibility.
18
(5) If a medical device is not accessible in a
19
nonvisual manner, a blind or low-vision individual is
20
unable to use it privately, independently, and safely.
21
(6) Many technology companies have incor-
22
porated screen access technology functions, such as
23
text to speech software, into products developed and
24
sold by such companies.
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•HR 1328 IH
(7) Screen access technology is not the only
1
mechanism by which medical devices can be made
2
accessible to blind or low-vision consumers.
3
(8) Devices that utilize these mechanisms will
4
be more user-friendly in general by including mul-
5
tiple methods to confirm readings and other data,
6
leading to less waste and fewer mistakes.
7
(9) Devices can be designed to work with non-
8
visual access technology used by individuals who are
9
blind or have low-vision at little or no extra cost as
10
long as such compatibility is taken into consider-
11
ation at the beginning of the design process.
12
(10) Consumers who are blind or have low-vi-
13
sion must be able to operate medical devices in an
14
equally effective and equally integrated manner and
15
with equivalent ease of use as consumers without
16
disabilities.
17
SEC. 3. NONVISUAL ACCESSIBILITY STANDARDS FOR CER-
18
TAIN DEVICES.
19
(a) IN GENERAL.—Section 501 of the Federal Food,
20
Drug, and Cosmetic Act (21 U.S.C. 351) is amended by
21
adding at the end the following:
22
‘‘(k)(1) Beginning on the effective date specified in
23
section 515D(d), if it is a covered device, unless the device
24
meets the nonvisual accessibility standard specified under
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•HR 1328 IH
section 515D or the Secretary issues a waiver with respect
1
to the device under subparagraph (2).
2
‘‘(2) The Secretary may waive the application of sub-
3
paragraph (1) with respect to a covered device if, based
4
on clear and convincing evidence (as determined by the
5
Secretary) provided by the manufacturer involved, the
6
Secretary determines that the application of such subpara-
7
graph to the device would result in a fundamental alter-
8
ation to the nature of the product or an undue hardship
9
for the manufacturer.
10
‘‘(3) In this paragraph:
11
‘‘(A) The term ‘covered device’ means a device
12
that—
13
‘‘(i) is classified under section 513 into
14
class II or III;
15
‘‘(ii) is cleared under section 510(k),
16
granted marketing authorization under section
17
513(f)(2), or approved under section 515 after
18
the effective date specified in section 515D(d);
19
‘‘(iii) has a user interface; and
20
‘‘(iv) is not intended solely for use by a
21
health care provider or in a setting outside the
22
home.
23
‘‘(B) The term ‘fundamental alteration’ means
24
an alteration to the nature of a covered device that
25
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•HR 1328 IH
would render it unusable or incapable of performing
1
an essential function.
2
‘‘(C)(i) The term ‘undue hardship’ means an
3
action requiring significant difficulty or expense,
4
when considered in light of the factors set forth in
5
clause (ii).
6
‘‘(ii) In determining whether application of this
7
subparagraph would impose an undue hardship on a
8
manufacturer of a covered device, factors to be con-
9
sidered may include—
10
‘‘(I) the nature and cost of compliance
11
with the standard under section 515D; and
12
‘‘(II) the overall financial resources of the
13
manufacturer of a covered device.
14
‘‘(D) The term ‘user interface’ means a screen
15
or mobile application through which a human user
16
interacts or communicates with the device by
17
inputting or receiving information.’’.
18
(b) RECOGNITION
OF
STANDARD.—The Federal
19
Food, Drug, and Cosmetic Act is amended by inserting
20
after section 515C (as added by Public Law 117–328) the
21
following:
22
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•HR 1328 IH
‘‘SEC. 515D. NONVISUAL ACCESSIBILITY STANDARDS FOR
1
CERTAIN DEVICES.
2
‘‘(a) STANDARD.—The nonvisual accessibility stand-
3
ard specified in this section is, with respect to a user inter-
4
face of a device described in section 501(k), that the user
5
interface is as effective in allowing blind or low-vision indi-
6
viduals to access information, engage in interactions, and
7
enjoy services with the same privacy, independence, and
8
ease of use as the user interface of the device enables indi-
9
viduals who do not have low-vision or are not blind.
10
‘‘(b) TRAINING.—The Secretary shall conduct train-
11
ing to educate manufacturers of a user interface of a de-
12
vice described in section 501(k) or of a device described
13
in such section on the standards developed under sub-
14
section (a) and how to comply with such standard.
15
‘‘(c) STAKEHOLDERS.—In developing the standard
16
under subsection (a) and the training to be conducted
17
under subsection (b), the Secretary shall consult with—
18
‘‘(1) the Architectural and Transportation Bar-
19
riers Compliance Board established under section
20
504 of the Rehabilitation Act of 1973; and
21
‘‘(2) individuals who are blind or who have low-
22
vision.
23
‘‘(d) REGULATIONS.—
24
‘‘(1) IN GENERAL.—The Secretary shall, in con-
25
sultation with the Architectural and Transportation
26
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•HR 1328 IH
Barriers Compliance Board referred to in subsection
1
(b)—
2
‘‘(A) not later than 1 year after the date
3
of the enactment of this section, issue proposed
4
regulations to implement the standard specified
5
under subsection (a); and
6
‘‘(B) not later than 2 years after the date
7
of the enactment of this section, publish a final
8
rule with respect to such proposed regulations.
9
‘‘(2) EFFECTIVE
DATE.—The final rule pub-
10
lished under paragraph (1)(B) shall take effect on
11
the date that is 1 year after the date on which such
12
rule is published.
13
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There
14
is authorized to be appropriated to carry out this section
15
$1,500,000 the period of fiscal years 2024 through
16
2025.’’.
17
Æ
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