; (ii) any combination of a drug or biological product described in clause (i); or (iii) when reasonably necessary to demonstrate sameness, biosimilarity, or interchangeability for purposes of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), as applicable, any product, including any device, that is marketed or intended for use with such drug or biological product; and (B) does not include any drug or biological product that the Secretary has determined to be currently in shortage and that appears on the drug shortage list in effect under section 506E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356e ), unless the shortage will not be promptly resolved— (i) as demonstrated by the fact that the drug or biological product has been in shortage for more than 6 months; or (ii) as otherwise determined by the Secretary; (2) the term device has the meaning given the term in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ); (3) the term eligible product developer means a person that seeks to develop a product for approval pursuant to an application for approval under subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or for licensing pursuant to an application under section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ); (4) the term license holder means the holder of an application approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or the holder of a license under subsection (a) or (k) of section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) for a covered product; (5) the term REMS means a risk evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1 )