### Question
What is the definition of affiliate?


### Answer
The definition of **affiliate** is as follows in *21 U.S.C. § 379i*:

> a business entity that has a relationship with a second business entity (whether domestic or international) if, directly or indirectly—


(A) one business entity controls, or has the power to control, the other business entity

#### 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**

