### Question
How is the "original device" defined?


### Answer
The term **original device** is defined in *21 U.S.C. § 321* as follows -

> a new, unused single-use device

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

