Page:United States Statutes at Large Volume 112 Part 2.djvu/638

 112 STAT. 1522 PUBLIC LAW 105-230—AUG. 13, 1998 (B) CERTAIN COMPONENTS.— Such term includes a manufactured piece of an implant that— (i) has significant non-implant applications; and (ii) alone, has no implant value or purpose, but when combined with other component parts and materials, constitutes an implant. (4) HARM.— (A) IN GENERAL.—The term "harm" means— (i) any injury to or damage suffered by an individual; (ii) any illness, disease, or death of that individual resulting from that injury or damage; and (iii) any loss to that individual or any other individual resulting from that injury or damage. (B) EXCLUSION. —The term does not include any commercial loss or loss of or damage to an implant. (5) IMPLANT. —The term "implant" means— (A) a medical device that is intended by the manufacturer of the device— (i) to be placed into a surgically or naturally formed or existing cavity of the body for a period of at least 30 days; or (ii) to remain in contact with bodily fluids or internal human tissue through a surgically produced opening for a period of less than 30 days; and (B) suture materials used in implant procedures. (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 510(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(a)(1))) of the implant; and (B) is required— (i) to register with the Secretary pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) 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 510(j) of such Act (21 U.S.C. 360(j)) and the regulations issued under such section. (7) MEDICAL DEVICE.— The term "medical device" means a device, as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)), and includes any device component of any combination product as that term is used in section 503(g) of such Act (21 U.S.C. 353(g)). (8) RAW MATERIAL.— The term "raw material" means a substance or product that— (A) has a generic use; and (B) may be used in an application other than an implant. (9) SECRETARY.—The term "Secretary" means the Secretary of Health and Human Services. (10) SELLER. — (A) IN GENERAL.—The term "seller" means a person who, in the course of a business conducted for that purpose.

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