### Question
How is the "rare pediatric disease" defined?


### Answer
The term **rare pediatric disease** is defined in *21 U.S.C. § 360ff* as follows -

> a disease that meets each of the following criteria:


(A) The disease primarily affects individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents

#### Citation:
  - *21 U.S.C. § 360ff*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part B-Drugs for Rare Diseases or Conditions**

