### Question
What does necessary mean?


### Answer
**Necessary** has the following meaning in *21 U.S.C. § 360c*:

> the minimum required information that would support a determination of substantial equivalence between a new device and a predicate 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**

