### Question
How is the "premarket notification submission" defined?


### Answer
The term **premarket notification submission** is defined in *21 U.S.C. § 379i* as follows -

> a report submitted under section 360(k) of this title

#### Citation:
  - *21 U.S.C. § 379i*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 3-fees relating to devices**

