II 

118TH CONGRESS 

2D SESSION S. 3621 

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 SENATE OF THE UNITED STATES 

JANUARY 18, 2024 

Ms. HASSAN (for herself and Mr. BRAUN) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medical Device Non5 visual Accessibility Act of 2024’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 

8 (1) Rapid advances in digital technology have 

9 led to increasingly complex user interfaces for everyVerDate Sep 11 2014 03:43 Jan 25, 2024 Jkt 049200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3621.IS S3621

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1 day products, such as life-sustaining medical devices 

2 and technologies. 

3 (2) Many of these new devices utilize displays 

4 that can only be operated visually and require user 

5 interaction with on-screen menus and other inter6 faces that are inaccessible to consumers who are 

7 blind or have low-vision. 

8 (3) Medical devices designed for use in the 

9 home are being increasingly utilized to lessen the 

10 cost of inpatient care for consumers. 

11 (4) Devices such as blood pressure monitors, 

12 sleep apnea machines, in-home chemotherapy treat13 ments, and many others generally lack nonvisual ac14 cessibility. 

15 (5) If a medical device is not accessible in a 

16 nonvisual manner, a blind or low-vision individual is 

17 unable to use it privately, independently, and safely. 

18 (6) Many technology companies have incor19 porated screen access technology functions, such as 

20 text to speech software, into products developed and 

21 sold by such companies. 

22 (7) Screen access technology is not the only 

23 mechanism by which medical devices can be made 

24 accessible to blind or low-vision consumers. 


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1 (8) Devices that utilize these mechanisms will 

2 be more user-friendly in general by including mul3 tiple methods to confirm readings and other data, 

4 leading to less waste and fewer mistakes. 

5 (9) Devices can be designed to work with non6 visual access technology used by individuals who are 

7 blind or have low-vision, at little or no extra cost, as 

8 long as such compatibility is taken into consider9 ation at the beginning of the design process. 

10 (10) Consumers who are blind or have low-vi11 sion must be able to operate medical devices in an 

12 equally effective and equally integrated manner and 

13 with equivalent ease of use as consumers without 

14 disabilities. 

15 SEC. 3. NONVISUAL ACCESSIBILITY STANDARDS FOR CER16 TAIN DEVICES. 

17 (a) IN GENERAL.—Section 501 of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 351) is amended by 

19 adding at the end the following: 

20 ‘‘(k)(1) Beginning on the effective date specified in 

21 section 515D(d)(2), if it is a covered device, unless the 

22 device meets the nonvisual accessibility standard specified 

23 under section 515D or the Secretary issues a waiver with 

24 respect to the device under subparagraph (2). 


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1 ‘‘(2) The Secretary may waive the application of sub2 paragraph (1) with respect to a covered device if, based 

3 on clear and convincing evidence (as determined by the 

4 Secretary) provided by the manufacturer involved, the 

5 Secretary determines that the application of such subpara6 graph to the device would result in a fundamental alter7 ation to the nature of the product or an undue hardship 

8 for the manufacturer. 

9 ‘‘(3) In this paragraph: 

10 ‘‘(A) The term ‘covered device’ means a device 

11 that— 

12 ‘‘(i) is classified under section 513 into 

13 class II or III; 

14 ‘‘(ii) is cleared under section 510(k), 

15 granted marketing authorization under section 

16 513(f)(2), or approved under section 515 after 

17 the effective date specified in section 

18 515D(d)(2); 

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 


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1 would render it unusable or incapable of performing 

2 an essential function. 

3 ‘‘(C)(i) The term ‘undue hardship’ means an 

4 action requiring significant difficulty or expense, 

5 when considered in light of the factors set forth in 

6 subclause (ii). 

7 ‘‘(ii) In determining whether application of sub8 paragraph (1) would impose an undue hardship on 

9 a manufacturer of a covered device, factors to be 

10 considered may include— 

11 ‘‘(I) the nature and cost of compliance 

12 with the standard under section 515D; and 

13 ‘‘(II) the overall financial resources of the 

14 manufacturer of a covered device. 

15 ‘‘(D) The term ‘user interface’ means a screen 

16 or mobile application through which a human user 

17 interacts or communicates with the device by 

18 inputting or receiving information.’’. 

19 (b) RECOGNITION OF STANDARD.—The Federal 

20 Food, Drug, and Cosmetic Act is amended by inserting 

21 after section 515C (21 U.S.C. 360e–4) the following: 

22 ‘‘SEC. 515D. NONVISUAL ACCESSIBILITY STANDARDS FOR 

23 CERTAIN DEVICES. 

24 ‘‘(a) STANDARD.—The nonvisual accessibility stand25 ard specified in this section is, with respect to a user interVerDate Sep 11 2014 03:43 Jan 25, 2024 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3621.IS S3621

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1 face of a device described in section 501(k), that the user 

2 interface is as effective in allowing blind or low-vision indi3 viduals to access information, engage in interactions, and 

4 enjoy services with the same privacy, independence, and 

5 ease of use as the user interface of the device enables indi6 viduals who do not have low-vision or are not blind. 

7 ‘‘(b) TRAINING.—The Secretary shall conduct train8 ing to educate manufacturers of a user interface of a de9 vice described in section 501(k) or of a device described 

10 in such section on the standards developed under sub11 section (a) and how to comply with such standard. 

12 ‘‘(c) STAKEHOLDERS.—In developing the standard 

13 under subsection (a) and the training to be conducted 

14 under subsection (b), the Secretary shall consult with— 

15 ‘‘(1) the Architectural and Transportation Bar16 riers Compliance Board established under section 

17 502 of the Rehabilitation Act of 1973; and 

18 ‘‘(2) individuals who are blind or who have low19 vision. 

20 ‘‘(d) REGULATIONS.— 

21 ‘‘(1) IN GENERAL.—The Secretary shall, in con22 sultation with the Architectural and Transportation 

23 Barriers Compliance Board referred to in subsection 

24 (c)(1)— 


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1 ‘‘(A) not later than 1 year after the date 

2 of the enactment of this section, issue proposed 

3 regulations to implement the standard specified 

4 under subsection (a); and 

5 ‘‘(B) not later than 2 years after the date 

6 of the enactment of this section, publish a final 

7 rule with respect to such proposed regulations. 

8 ‘‘(2) EFFECTIVE DATE.—The final rule pub9 lished under paragraph (1)(B) shall take effect on 

10 the date that is 1 year after the date on which such 

11 rule is published.’’. 

Æ 


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