premarket application
Defined in 1 place of the United States Code.
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.
Source
- 2016–present21 U.S.C. § 379IFood and Drugs · Definitions · for purposes of this subpart
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.
Such term does not include a supplement, a premarket report, or a premarket notification submission.
Source
- 2002–202621 U.S.C. § 379IFood and Drugs · Definitions · for purposes of this subpart