### Question
What is the definition of establishment subject to a registration fee?


### Answer
The definition of **establishment subject to a registration fee** is as follows in *21 U.S.C. § 379i*:

> an establishment that is required to register with the Secretary under section 360 of this title and is one of the following types of establishments:


#### (A) Manufacturer


An establishment that makes by any means any article that is a device, including an establishment that sterilizes or otherwise makes such article for or on behalf of a specification developer or any other person

#### Citation:
  - *21 U.S.C. § 379i*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 3-fees relating to devices**

