As used in this chapter:
((1)) ** Biomaterials supplier**
((A)) ** In general** 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)) ** 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.
((2)) ** Claimant**
((A)) ** In general** 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)) ** Action brought on behalf of an estate** 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)) ** Action brought on behalf of a minor or incompetent** 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)) ** Exclusions** 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—
((aa)) be disclosed to a jury in any civil action or other proceeding; and
((bb)) except as necessary to establish the applicability of this chapter, otherwise be presented in any civil action or other proceeding.
((3)) ** Component part**
((A)) ** In general** The term “component part” means a manufactured piece of an implant.
((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 ) of the implant; and
((B)) is required—
((i)) to register with the Secretary pursuant to and the regulations issued under such section; and
((ii)) to include the implant on a list of devices filed with the Secretary pursuant to and the regulations issued under such section.
((7)) ** Medical device** The term “medical device” means a device, as defined in , and includes any device component of any combination product as that term is used in .section 321(h) of this titlesection 353(g) of this title
((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, sells, distributes, leases, packages, labels, or otherwise places an implant in the stream of commerce.
((B)) ** Exclusions** 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.