### Question
What does applicable manufacturer mean?


### Answer
**Applicable manufacturer** has the following meaning in *42 U.S.C. § 1320a*:

> a manufacturer of a covered drug, device, biological, or medical supply which is operating in the United States, or in a territory, possession, or commonwealth of the United States

#### Citation:
  - *42 U.S.C. § 1320a*
  - Heading: **CHAPTER 7-SOCIAL SECURITY > SUBCHAPTER XI-GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE SIMPLIFICATION > Part A-General Provisions**

