### Question
How is the "contrast agent" defined?


### Answer
The term **contrast agent** is defined in *21 U.S.C. § 360j* as follows -

> a drug that is approved under section 355 of this title or licensed under section 262 of title 42, is intended for use in conjunction with an applicable medical imaging device, and—


(i) is a diagnostic radiopharmaceutical, as defined in section [2](#360j_2_target) 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations)

#### Citation:
  - *21 U.S.C. § 360j*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part A-Drugs and Devices**

