market clearance
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 353 — in this section (12 versions over time)
The term “market clearance” includes—
(i) approval of an application under section 355, 357,4 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.