### Question
How does DEFINITIONS define original device?


### Answer
Under *21 U.S.C. § 321*, **original device** is defined as:

> a new, unused single-use device

#### Citation:
  - *21 U.S.C. § 321*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER II-DEFINITIONS**

