### Question
How is the "pediatric patients" defined?


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

> patients who are 21 years of age or younger at the time of the diagnosis or treatment

#### 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**

