; (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 means an alteration to the nature of a covered device that would render it unusable or incapable of performing an essential function. (C) (i) The term undue hardship means an action requiring significant difficulty or expense, when considered in light of the factors set forth in clause (ii). (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