### Question
How is the "annual distribution number" defined?


### Answer
The term **annual distribution number** is defined in *21 U.S.C. § 360j* as follows -

> the number of such devices reasonably needed to treat, diagnose, or cure a population of 8,000 individuals in the United States

#### 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**

