,,ii #aahth ,,congress #b;d ,session ,s4 #cfba ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,january #ah1 #bjbd,ms4 ,hassan 7for herself and ,mr4 ,braun7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to establish nonvisual accessibility standards for certain devices with digital interfaces1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,medical ,device ,nonvisual ,accessibility ,act of #bjbd4 #b4 ,findings ,congress finds the following3 7#a7 ,rapid advances in digital technology have led to increasingly complex user interfaces for everyday products1 such as life-sustaining medical devices and technologies4 7#b7 ,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-vision4 7#c7 ,medical devices designed for use in the home are being increasingly utilized to lessen the cost of inpatient care for consumers4 7#d7 ,devices such as blood pressure monitors1 sleep apnea machines1 in-home chemotherapy treatments1 and many others generally lack nonvisual accessibility4 7#e7 ,if a medical device is not accessible in a nonvisual manner1 a blind or low-vision individual is unable to use it privately1 independently1 and safely4 7#f7 ,many technology companies have incorporated screen access technology functions1 such as text to speech software1 into products developed and sold by such companies4 7#g7 ,screen access technology is not the only mechanism by which medical devices can be made accessible to blind or low-vision consumers4 7#h7 ,devices that utilize these mechanisms will be more user-friendly in general by including multiple methods to confirm readings and other data1 leading to less waste and fewer mistakes4 7#i7 ,devices can be designed to work with nonvisual access technology used by individuals who are blind or have low-vision1 at little or no extra cost1 as long as such compatibility is taken into consideration at the beginning of the design process4 7#aj7 ,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 disabilities4 #c4 ,nonvisual accessibility standards for certain devices 7a7 ,in general ,section #eja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea7 is amended by adding at the end the following3 7k7 7#a7 ,beginning on the effective date specified in section #eae;,d7d77#b71 if it is a covered device1 unless the device meets the nonvisual accessibility standard specified under section #eae;,d or the ,secretary issues a waiver with respect to the device under subparagraph 7#b74 7#b7 ,the ,secretary may waive the application of subparagraph 7#a7 with respect to a covered device if1 based on clear and convincing evidence 7as determined by the ,secretary7 provided by the manufacturer involved1 the ,secretary determines that the application of such subparagraph to the device would result in a fundamental alteration to the nature of the product or an undue hardship for the manufacturer4 7#c7 ,in this paragraph3 7,a7 ,the term covered device means a device that-- 7i7 is classified under section #eac into class ,,ii or ,,iii2 7ii7 is cleared under section #eaj7k71 granted marketing authorization under section #eac7;f77#b71 or approved under section #eae after the effective date specified in section #eae;,d7d77#b72 7iii7 has a user interface2 and 7iv7 is not intended solely for use by a health care provider or in a setting outside the home4 7,b7 ,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 function4 7,c7 7i7 ,the term undue hardship means an action requiring significant difficulty or expense1 when considered in light of the factors set forth in subclause 7ii74 7ii7 ,in determining whether application of subparagraph 7#a7 would impose an undue hardship on a manufacturer of a covered device1 factors to be considered may include-- 7,i7 the nature and cost of compliance with the standard under section #eae;,d2 and 7,,ii7 the overall financial resources of the manufacturer of a covered device4 7,d7 ,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 information4 4 7b7 ,recognition of standard ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #eae;,c 7#ba ,u4,s4,c4 #cfj;e-#d7 the following3 #eae;,d4 ,nonvisual accessibility standards for certain devices 7a7 ,standard ,the nonvisual accessibility standard specified in this section is1 with respect to a user interface of a device described in section #eja7k71 that the user interface is as effective in allowing blind or low-vision individuals to access information1 engage in interactions1 and enjoy services with the same privacy1 independence1 and ease of use as the user interface of the device enables individuals who do not have low-vision or are not blind4 7b7 ,training ,the ,secretary shall conduct training to educate manufacturers of a user interface of a device described in section #eja7k7 or of a device described in such section on the standards developed under subsection 7a7 and how to comply with such standard4 7c7 ,stakeholders ,in developing the standard under subsection 7a7 and the training to be conducted under subsection 7b71 the ,secretary shall consult with-- 7#a7 the ,architectural and ,transportation ,barriers ,compliance ,board established under section #ejb of the ,rehabilitation ,act of #aigc2 and 7#b7 individuals who are blind or who have low-vision4 7d7 ,regulations 7#a7 ,in general ,the ,secretary shall1 in consultation with the ,architectural and ,transportation ,barriers ,compliance ,board referred to in subsection 7c77#a7-- 7,a7 not later than #a year after the date of the enactment of this section1 issue proposed regulations to implement the standard specified under subsection 7a72 and 7,b7 not later than #b years after the date of the enactment of this section1 publish a final rule with respect to such proposed regulations4 7#b7 ,effective date ,the final rule published under paragraph 7#a77;,b7 shall take effect on the date that is #a year after the date on which such rule is published4 4