### Question
How is the "manufacturer" defined?


### Answer
The term **manufacturer** is defined in *21 U.S.C. § 1602* as follows -

> any person who, with respect to an implant—


(A) is engaged in the manufacture, preparation, propagation, compounding, or processing (as defined in section 360(a)(1) of this title) of the implant

#### Citation:
  - *21 U.S.C. § 1602*
  - Heading: **CHAPTER 21-BIOMATERIALS ACCESS ASSURANCE**

