premarket application
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 379I — for purposes of this subpart (8 versions over time)
The term “premarket application” means—
(A) an application for approval of a device submitted under section 360e(c) of this title or section 262 of title 42; or
(B) a product development protocol described in section 360e(f) of this title.