# § 1602. Definitions
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 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)** **Medical device** section 321(h) of this titlesection 353(g) of this title
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 .
**(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.
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**Source Credit**: (Pub. L. 105–230, § 3, Aug. 13, 1998, 112 Stat. 1520.)
## Statutory Notes and Related Subsidiaries
### Effective Date
Section applicable to all civil actions covered under this chapter commenced on or after , including any in which the harm or harmful conduct occurred before such date, see , set out as a note under .