establishment subject to a registration fee
Defined in 1 place of the United States Code.
The term “establishment subject to a registration fee” means an establishment that is registered (or is required to register) with the Secretary under section 360 of this title because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device.
Source
- 2012–present21 U.S.C. § 379IFood and Drugs · Definitions · for purposes of this subpart
The term “establishment subject to a registration fee” means 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.
(B) Single-use device reprocessor
An establishment that, within the meaning of section 321(ll)(2)(A) of this title, performs additional processing and manufacturing operations on a single-use device that has previously been used on a patient.
(C) Specification developer
An establishment that develops specifications for a device that is distributed under the establishment's name but which performs no manufacturing, including an establishment that, in addition to developing specifications, also arranges for the manufacturing of devices labeled with another establishment's name by a contract manufacturer.
Source
- 2007–201221 U.S.C. § 379IFood and Drugs · Definitions · for purposes of this subpart