### Question
How does the law define de novo classification request?


### Answer
Under *21 U.S.C. § 379i*, **de novo classification request** is defined as:

> a request made under section 360c(f)(2)(A) of this title with respect to the classification of a device

#### 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**

