21 U.S.C. § 1602 (FOOD AND DRUGS)
§ 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
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) 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.
(Pub. L. 105–230, § 3, Aug. 13, 1998, 112 Stat. 1520.)