### Question
How is the term new use defined?


### Answer
The term **new use** is defined in *21 U.S.C. § 355* as the following:

> a use of a contrast agent that is described in the approved labeling of an applicable medical imaging device described in section 360j(p) of this title, but that is not described in the approved labeling of the contrast agent

#### Citation:
  - *21 U.S.C. § 355*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part A-Drugs and Devices**

