premarket application

(1) 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.


21 USC § 379i(1)

Scoping language

For purposes of this subpart
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