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 ) is amended by adding at the end the following: (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) The Secretary may waive the application of subparagraph (1) 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 subparagraph to the device would result in a fundamental alteration to the nature of the product or an undue hardship for the manufacturer. (3) In this paragraph: (A) The term covered device means a device that— (i) is classified under section 513 into class II or III