qualified pandemic or epidemic product
(7) Qualified pandemic or epidemic product The term “qualified pandemic or epidemic product” means a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) ), biological product (as such term is defined by section 262(i) of this title ), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act ( 21 U.S.C. 321(h) ) (A) (i) a product manufactured, used, designed, developed, modified, licensed, or procured— (I) to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic; or (II) to limit the harm such pandemic or epidemic might otherwise cause; (ii) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in clause (i); or (iii) a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii); and (B) (i) approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 351 et seq.] or licensed under section 262 of this title ; (ii) the object of research for possible use as described by subparagraph (A) and is the subject of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(i) , 360j(g)]; or (iii) authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 360bbb–3 , 360bbb–3a, 360bbb–3b].