
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC1602]

 
                        TITLE 21--FOOD AND DRUGS
 
                CHAPTER 21--BIOMATERIALS ACCESS ASSURANCE
 
Sec. 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, Sec. 3, Aug. 13, 1998, 112 Stat. 1520.)
