### Question
How does DRUGS AND DEVICES define necessary?


### Answer
Under *21 U.S.C. § 360c*, **necessary** is defined as:

> the minimum required information that would support a determination by the Secretary that an application provides reasonable assurance of the effectiveness of the device

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

