market clearance

(C)The term “market clearance” includes— (i)approval of an application under section 355, 357,4360e, 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 undersection 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 underor under section 351 of the Public Health Service Act [42 U.S.C. 262], including with respect to investigational use of the product.

Source

21 USC § 353(iii)(9)(C)


Scoping language

None: Default is title Scope
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