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 Georgia, 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 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 2023’’. 


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1 SEC. 2. FINDINGS. 

2 Congress finds the following: 

3 (1) Rapid advances in digital technology have 

4 led to increasingly complex user interfaces for every5 day products, such as life-sustaining medical devices 

6 and technologies. 

7 (2) Many of these new devices utilize displays 

8 that can only be operated visually and require user 

9 interaction with on-screen menus and other inter10 faces that are inaccessible to consumers who are 

11 blind or have low-vision. 

12 (3) Medical devices designed for use in the 

13 home are being increasingly utilized to lessen the 

14 cost of inpatient care for consumers. 

15 (4) Devices such as blood pressure monitors, 

16 sleep apnea machines, in-home chemotherapy treat17 ments, and many others generally lack nonvisual ac18 cessibility. 

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

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

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

22 (6) Many technology companies have incor23 porated screen access technology functions, such as 

24 text to speech software, into products developed and 

25 sold by such companies. 


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1 (7) Screen access technology is not the only 

2 mechanism by which medical devices can be made 

3 accessible to blind or low-vision consumers. 

4 (8) Devices that utilize these mechanisms will 

5 be more user-friendly in general by including mul6 tiple methods to confirm readings and other data, 

7 leading to less waste and fewer mistakes. 

8 (9) Devices can be designed to work with non9 visual access technology used by individuals who are 

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

11 long as such compatibility is taken into consider12 ation at the beginning of the design process. 

13 (10) Consumers who are blind or have low-vi14 sion must be able to operate medical devices in an 

15 equally effective and equally integrated manner and 

16 with equivalent ease of use as consumers without 

17 disabilities. 

18 SEC. 3. NONVISUAL ACCESSIBILITY STANDARDS FOR CER19 TAIN DEVICES. 

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

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

22 adding at the end the following: 

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

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

25 meets the nonvisual accessibility standard specified under 


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1 section 515D or the Secretary issues a waiver with respect 

2 to the device under subparagraph (2). 

3 ‘‘(2) The Secretary may waive the application of sub4 paragraph (1) with respect to a covered device if, based 

5 on clear and convincing evidence (as determined by the 

6 Secretary) provided by the manufacturer involved, the 

7 Secretary determines that the application of such subpara8 graph to the device would result in a fundamental alter9 ation to the nature of the product or an undue hardship 

10 for the manufacturer. 

11 ‘‘(3) In this paragraph: 

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

13 that— 

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

15 class II or III; 

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

17 granted marketing authorization under section 

18 513(f)(2), or approved under section 515 after 

19 the effective date specified in section 515D(d); 

20 ‘‘(iii) has a user interface; and 

21 ‘‘(iv) is not intended solely for use by a 

22 health care provider or in a setting outside the 

23 home. 

24 ‘‘(B) The term ‘fundamental alteration’ means 

25 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 clause (ii). 

7 ‘‘(ii) In determining whether application of this 

8 subparagraph would impose an undue hardship on a 

9 manufacturer of a covered device, factors to be con10 sidered 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 (as added by Public Law 117–328) the 

22 following: 


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

2 CERTAIN DEVICES. 

3 ‘‘(a) STANDARD.—The nonvisual accessibility stand4 ard specified in this section is, with respect to a user inter5 face of a device described in section 501(k), that the user 

6 interface is as effective in allowing blind or low-vision indi7 viduals to access information, engage in interactions, and 

8 enjoy services with the same privacy, independence, and 

9 ease of use as the user interface of the device enables indi10 viduals who do not have low-vision or are not blind. 

11 ‘‘(b) TRAINING.—The Secretary shall conduct train12 ing to educate manufacturers of a user interface of a de13 vice described in section 501(k) or of a device described 

14 in such section on the standards developed under sub15 section (a) and how to comply with such standard. 

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

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

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

19 ‘‘(1) the Architectural and Transportation Bar20 riers Compliance Board established under section 

21 504 of the Rehabilitation Act of 1973; and 

22 ‘‘(2) individuals who are blind or who have low23 vision. 

24 ‘‘(d) REGULATIONS.— 

25 ‘‘(1) IN GENERAL.—The Secretary shall, in con26 sultation with the Architectural and Transportation 


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1 Barriers Compliance Board referred to in subsection 

2 (b)— 

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

4 of the enactment of this section, issue proposed 

5 regulations to implement the standard specified 

6 under subsection (a); and 

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

8 of the enactment of this section, publish a final 

9 rule with respect to such proposed regulations. 

10 ‘‘(2) EFFECTIVE DATE.—The final rule pub11 lished under paragraph (1)(B) shall take effect on 

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

13 rule is published. 

14 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

15 is authorized to be appropriated to carry out this section 

16 $1,500,000 the period of fiscal years 2024 through 

17 2025.’’. 

Æ 


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