manufacturer

(6) Manufacturer The term “manufacturer” means 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; and (B) is required— (i) to register with the Secretary pursuant to section 360 of this title and the regulations issued under such section; and (ii) to include the implant on a list of devices filed with the Secretary pursuant to section 360(j) of this title and the regulations issued under such section.

Source

21 USC § 1602(6)


Scoping language

None identified. Default scope is assumed to be the entire title.
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