(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.

(a) In general

The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 515C (as added by Public Law 117–328) the following:

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 comparable 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) Waiver

The Secretary may waive the application of section 501(k) with respect to a covered device if, based on clear and convincing evidence (as determined by the Secretary) provided by the manufacturer involved, the Secretary determines that the application of such section to the device would result in a fundamental alteration to the nature of the product or an undue hardship for the manufacturer.

(c) 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.

(d) Stakeholders

In developing the standard under subsection (a) and the training to be conducted under subsection (c), 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.

(e) Regulations

(1) In general

The Secretary shall, in consultation with the Architectural and Transportation Barriers Compliance Board referred to in subsection (d)—

(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.

(f) Definitions

In this section:

(1)

The term covered device means a device that—

(A)

is classified under section 513 into class II or III;

(B)

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 subsection (e);

(C)

has a user interface; and

(D)

is not intended solely for use by a health care provider or in a setting outside the home.

(2)

The term fundamental alteration means an alteration to the nature of a covered device that would render it unusable or incapable of performing an essential function.

(3)

(A)

The term undue hardship means an action requiring significant difficulty or expense, when considered in light of the factors specified in subparagraph (B).

(B)

In determining whether application of this section would impose an undue hardship on a manufacturer of a covered device, factors to be considered may include

(C)

the nature and cost of compliance with the standard under this section; and

(D)

the overall financial resources of the manufacturer of a covered device.

(4)

The term user interface means a screen or mobile application through which a human user interacts or communicates with the device by inputting or receiving information.

(b) Adulteration

Section 501 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended by inserting after paragraph (j) the following:

(k)

Beginning on the effective date specified in subsection (e) of section 515D, if it is a covered device (as defined in such section), unless the device meets the nonvisual accessibility standard specified under such section or the Secretary issues a waiver with respect to the device under such section.