§ 1602. Definitions

As used in this chapter:

• (1)
  • (A) The term “biomaterials supplier” means an entity that directly or indirectly supplies a component part or raw material for use in the manufacture of an implant.
  • (B) 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.
• (2)
  • (A) The term “claimant” means any person who brings a civil action, or on whose behalf a civil action is brought, arising from harm allegedly caused directly or indirectly by an implant, including a person other than the individual into whose body, or in contact with whose blood or tissue, the implant is placed, who claims to have suffered harm as a result of the implant.
  • (B) With respect to an action brought on behalf of or through the estate of a deceased individual into whose body, or in contact with whose blood or tissue the implant was placed, such term includes the decedent that is the subject of the action.
  • (C) With respect to an action brought on behalf of or through a minor or incompetent, such term includes the parent or guardian of the minor or incompetent.
  • (D) Such term does not include—
    • (i) a provider of professional health care services in any case in which—
      • (I) the sale or use of an implant is incidental to such services; and
      • (II) the essence of the professional health care services provided is the furnishing of judgment, skill, or services;
    • (ii) a person acting in the capacity of a manufacturer, seller, or biomaterials supplier; or
    • (iii) a person alleging harm caused by either the silicone gel or the silicone envelope utilized in a breast implant containing silicone gel, except that—
      • (I) neither the exclusion provided by this clause nor any other provision of this chapter may be construed as a finding that silicone gel (or any other form of silicone) may or may not cause harm; and
      • (II) the existence of the exclusion under this clause may not—
• (3)
  • (A) The term “component part” means a manufactured piece of an implant.
  • (B) 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)
  • (A) 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) The term does not include any commercial loss or loss of or damage to an implant.
• (5) 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) 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.
• (7) The term “medical device” means a device, as defined in section 321(h) of this title , and includes any device component of any combination product as that term is used in section 353(g) of this title .
• (8) 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) The term “Secretary” means the Secretary of Health and Human Services.
• (10)
  • (A) The term “seller” means a person who, in the course of a business conducted for that purpose, sells, distributes, leases, packages, labels, or otherwise places an implant in the stream of commerce.
  • (B) The term does not include—
    • (i) a seller or lessor of real property;
    • (ii) a provider of professional health care services in any case in which—
      • (I) the sale or use of the implant is incidental to such services; and
      • (II) the essence of the professional health care services provided is the furnishing of judgment, skill, or services; or
    • (iii) any person who acts in only a financial capacity with respect to the sale of an implant.