Page:United States Statutes at Large Volume 112 Part 2.djvu/635

 PUBLIC LAW 105-230—AUG. 13, 1998 112 STAT. 1519 Public Law 105-230 105th Congress An Act To establish rules governing product liability actions against raw materials and Aug. 13, 1998 bulk component suppliers to medical device manufacturers, and for other purposes. [H'. R. 872] Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, Biomaterials Access Assurance SECTION 1. SHORT TITLE. Act of 1998. 21 USC 1601 This Act may be cited as the "Biomaterials Access Assurance note. Act of 1998". SEC. 2. FINDINGS. ' 21 USC 1601. 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 Federsu 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;

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