
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: 21USC1601]

 
                        TITLE 21--FOOD AND DRUGS
 
                CHAPTER 21--BIOMATERIALS ACCESS ASSURANCE
 
Sec. 1601. Findings

    The Congress finds that--
        (1) each year millions of citizens of the United States depend 
    on the availability of lifesaving or life-enhancing medical devices, 
    many of which are permanently implantable within the human body;
        (2) a continued supply of raw materials and component parts is 
    necessary for the invention, development, improvement, and 
    maintenance of the supply of the devices;
        (3) most of the medical devices are made with raw materials and 
    component parts that--
            (A) move in interstate commerce;
            (B) are not designed or manufactured specifically for use in 
        medical devices; and
            (C) come in contact with internal human tissue;

        (4) the raw materials and component parts also are used in a 
    variety of nonmedical products;
        (5) because small quantities of the raw materials and component 
    parts are used for medical devices, sales of raw materials and 
    component parts for medical devices constitute an extremely small 
    portion of the overall market for the raw materials and component 
    parts;
        (6) under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
    301 et seq.) manufacturers of medical devices are required to 
    demonstrate that the medical devices are safe and effective, 
    including demonstrating that the products are properly designed and 
    have adequate warnings or instructions;
        (7) notwithstanding the fact that raw materials and component 
    parts suppliers do not design, produce, or test a final medical 
    device, the suppliers have been the subject of actions alleging 
    inadequate--
            (A) design and testing of medical devices manufactured with 
        materials or parts supplied by the suppliers; or
            (B) warnings related to the use of such medical devices;

        (8) even though suppliers of raw materials and component parts 
    have very rarely been held liable in such actions, such suppliers 
    have ceased supplying certain raw materials and component parts for 
    use in medical devices for a number of reasons, including concerns 
    about the costs of such litigation;
        (9) unless alternate sources of supply can be found, the 
    unavailability of raw materials and component parts for medical 
    devices will lead to unavailability of lifesaving and life-enhancing 
    medical devices;
        (10) because other suppliers of the raw materials and component 
    parts in foreign nations are refusing to sell raw materials or 
    component parts for use in manufacturing certain medical devices in 
    the United States, the prospects for development of new sources of 
    supply for the full range of threatened raw materials and component 
    parts for medical devices are remote;
        (11) it is unlikely that the small market for such raw materials 
    and component parts in the United States could support the large 
    investment needed to develop new suppliers of such raw materials and 
    component parts;
        (12) attempts to develop such new suppliers would raise the cost 
    of medical devices;
        (13) courts that have considered the duties of the suppliers of 
    the raw materials and component parts have generally found that the 
    suppliers do not have a duty--
            (A) to evaluate the safety and efficacy of the use of a raw 
        material or component part in a medical device; or
            (B) to warn consumers concerning the safety and 
        effectiveness of a medical device;

        (14) because medical devices and the raw materials and component 
    parts used in their manufacture move in interstate commerce, a 
    shortage of such raw materials and component parts affects 
    interstate commerce;
        (15) in order to safeguard the availability of a wide variety of 
    lifesaving and life-enhancing medical devices, immediate action is 
    needed--
            (A) to clarify the permissible bases of liability for 
        suppliers of raw materials and component parts for medical 
        devices; and
            (B) to provide expeditious procedures to dispose of 
        unwarranted suits against the suppliers in such manner as to 
        minimize litigation costs;

        (16) the several States and their courts are the primary 
    architects and regulators of our tort system; Congress, however, 
    must, in certain circumstances involving the national interest, 
    address tort issues, and a threatened shortage of raw materials and 
    component parts for lifesaving medical devices is one such 
    circumstance; and
        (17) the protections set forth in this chapter are needed to 
    assure the continued supply of materials for lifesaving medical 
    devices, although such protections do not protect negligent 
    suppliers.

(Pub. L. 105-230, Sec. 2, Aug. 13, 1998, 112 Stat. 1519.)

                       References in Text

    The Federal Food, Drug, and Cosmetic Act, referred to in par. (6), 
is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is 
classified generally to chapter 9 (Sec. 301 et seq.) of this title. For 
complete classification of this Act to the Code, see section 301 of this 
title and Tables.


                             Effective Date

    Pub. L. 105-230, Sec. 8, Aug. 13, 1998, 112 Stat. 1529, provided 
that: ``This Act [enacting this chapter] shall apply to all civil 
actions covered under this Act that are commenced on or after the date 
of enactment of this Act [Aug. 13, 1998], including any such action with 
respect to which the harm asserted in the action or the conduct that 
caused the harm occurred before the date of enactment of this Act.''


                               Short Title

    Pub. L. 105-230, Sec. 1, Aug. 13, 1998, 112 Stat. 1519, provided 
that: ``This Act [enacting this chapter] may be cited as the 
`Biomaterials Access Assurance Act of 1998'.''
