WHAT IS A BIOMATERIALS SUPPLIER?
As defined in the act a biomaterials supplier is any entity that directly or indirectly supplies a component part or raw material for use in the manufacture of an implant, a component part is a manufactured piece of an implant that has nonimplant applications, and a raw material refers to a product with generic applications that may be used in a nonimplant application. A medical device is a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act, codified in 21 U.S.C. 321(h), and includes any device component of any combination product as the latter term is used in 21 U.S.C. 353(g). The biomaterials act also broadly defines an implant as a medical device that is intended to be “placed into a surgically or naturally formed or existing cavity of the body for a period of at least 30 days,” or that will “remain in contact with bodily fluids or internal human tissue through a surgically produced opening for a period of less than 30 days,” or that is a suture material
