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According to 21 USCS § 1602, the term "biomaterials supplier" means “(A) an entity that directly or indirectly supplies a component part or raw material for use in the manufacture of an implant.
(B) Persons included. Such term includes any person who--
(i) has submitted master files to the Secretary for purposes of premarket approval of a medical device; or
(ii) licenses a biomaterials supplier to produce component parts or raw materials.”