### Question
What is the definition of annual distribution number?


### Answer
The definition of **annual distribution number** is as follows in *21 U.S.C. § 360j*:

> the number of such devices reasonably needed to treat, diagnose, or cure a population of 4,000 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**

