Medical Device Nonvisual Accessibility Act of 2023

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. Short title This Act may be cited as the Medical Device Nonvisual Accessibility Act of 2023 2. Findings Congress finds the following: (1) Rapid advances in digital technology have led to increasingly complex user interfaces for everyday 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 interfaces 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 treatments, and many others generally lack nonvisual accessibility. (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 incorporated screen access technology functions, such as text to speech software, 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) Devices that utilize these mechanisms will be more user-friendly in general by including multiple methods to confirm readings and other data, leading to less waste and fewer mistakes. (9) Devices can be designed to work with nonvisual 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 consideration at the beginning of the design process. (10) Consumers who are blind or have low-vision 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. 3. Nonvisual accessibility standards for certain devices (a) In general Section 501 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 (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 section 515D or the Secretary issues a waiver with respect to the device under subparagraph (2). (2) (3) In this paragraph: (A) The term covered device (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 (C) (i) The term undue hardship (ii) In determining whether application of this subparagraph would impose an undue hardship on a manufacturer of a covered device, factors to be considered 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 . (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 515D. Nonvisual accessibility standards for certain devices (a) Standard The nonvisual accessibility standard specified in this section is, with respect to a user interface of a device described in section 501(k), that the user interface is as effective in allowing blind or low-vision individuals 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 individuals who do not have low-vision or are not blind. (b) Training The Secretary shall conduct training to educate manufacturers of a user interface of a device described in section 501(k) or of a device described in such section on the standards developed under subsection (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 Barriers 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 consultation with the Architectural and Transportation 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 published 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. .

Summary: Medical Device Nonvisual Accessibility Act of 2023 This bill requires certain medical devices with a digital interface to meet nonvisual accessibility standards established by the Food and Drug Administration (FDA). Specifically, the FDA must establish regulations to require a Class II or Class III medical device with a digital interface to provide a blind or low-vision user access to the same services and information, and generally the same ease of use, as provided to a user who is not low-vision or blind. (The FDA classifies medical devices in three classes. Class I devices are low-risk, Class II devices are moderate-risk, and Class III devices are high-risk.) A Class II or Class III medical device that does not meet the nonvisual accessibility standards established under this bill may not be sold. However, the FDA may waive the bill's requirements for a device upon a showing that applying the standards would fundamentally alter the nature of the device or create an undue hardship for the manufacturer. The bill also does not apply to devices that are intended solely for use by a health care provider or in a setting outside the home.