(9) As used in this subsection: (A) The term “agency center” means a center or alternative organizational component of the Food and Drug Administration. (B) The term “biological product” has the meaning given the term in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) ). (C) The term “market clearance” includes— (i) approval of an application under section 355, 357, 360e, or 360j(g) of this title; (ii) a finding of substantial equivalence under this part; (iii) approval of a biologics license application under subsection (a) of section 351 of the Public Health Service Act ( 42 U.S.C. 262 ); and (iv) de novo classification under section 360c(a)(1) of this title . (D) The terms “premarket review” and “reviews” include all activities of the Food and Drug Administration conducted prior to approval or clearance of an application, notification, or request for classification submitted under section 355 , 360(k) , 360c(f)(2) , 360e , or 360j of this title or under section 351 of the Public Health Service Act [ 42 U.S.C. 262 ], including with respect to investigational use of the product.