### Question
How does DEFINITIONS define semi-critical reprocessed single-use device?


### Answer
Under *21 U.S.C. § 321*, **semi-critical reprocessed single-use device** is defined as:

> a reprocessed single-use device that is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body

#### Citation:
  - *21 U.S.C. § 321*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER II-DEFINITIONS**

