21 U.S.C. § 1541 — Untitled legal text

Page 950 TITLE 21—FOOD AND DRUGS §§ 1541 to 1548 Editorial Notes REFERENCES IN TEXT The Drug-Free Communities Act of 1997, referred to in subsec. (a)(3), is Pub. L. 105–20, June 27, 1997, 111 Stat. 224, section 2(a)(2) of which enacted chapter 2 of the National Narcotics Leadership Act of 1988, which is classified to this subchapter. For complete classifica- tion of the Drug-Free Communities Act of 1997 to the Code, see Short Title of 1997 Amendment note set out under section 1501 of this title and Tables. CODIFICATION Section was enacted as part of the Comprehensive Addiction and Recovery Act of 2016, and not as part of the National Narcotics Leadership Act of 1988 which comprises this chapter. PART B—ADVISORY COMMISSION §§ 1541 to 1548. Repealed. Pub. L. 115–271, title VIII, § 8203(b)(5), Oct. 24, 2018, 132 Stat. 4112; Pub. L. 116–74, § 2(c)(1)(A)(ii)(II), Nov. 27, 2019, 133 Stat. 1157 Section 1541, Pub. L. 100–690, title I, § 1041, as added Pub. L. 105–20, § 2(a)(2), June 27, 1997, 111 Stat. 231, es- tablished Advisory Commission on Drug-Free Commu- nities. Section 1542, Pub. L. 100–690, title I, § 1042, as added Pub. L. 105–20, § 2(a)(2), June 27, 1997, 111 Stat. 231, re- lated to duties of the Commission. Section 1543, Pub. L. 100–690, title I, § 1043, as added Pub. L. 105–20, § 2(a)(2), June 27, 1997, 111 Stat. 232, re- lated to membership of the Commission. Section 1544, Pub. L. 100–690, title I, § 1044, as added Pub. L. 105–20, § 2(a)(2), June 27, 1997, 111 Stat. 232, re- lated to compensation. Section 1545, Pub. L. 100–690, title I, § 1045, as added Pub. L. 105–20, § 2(a)(2), June 27, 1997, 111 Stat. 233, re- lated to terms of office. Section 1546, Pub. L. 100–690, title I, § 1046, as added Pub. L. 105–20, § 2(a)(2), June 27, 1997, 111 Stat. 233, re- lated to Commission meetings. Section 1547, Pub. L. 100–690, title I, § 1047, as added Pub. L. 105–20, § 2(a)(2), June 27, 1997, 111 Stat. 233, re- lated to Commission staff. Section 1548, Pub. L. 100–690, title I, § 1048, as added Pub. L. 105–20, § 2(a)(2), June 27, 1997, 111 Stat. 234; amended Pub. L. 107–82, § 3, Dec. 14, 2001, 115 Stat. 820, terminated the Commission at the end of fiscal year 2007. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2019 AMENDMENT Amendment by Pub. L. 116–74 effective as if included in the enactment of subtitle K of title VIII of Pub. L. 115–271, see section 2(c)(2) of Pub. L. 116–74, set out a note under section 1522 of this title. CHAPTER 21—BIOMATERIALS ACCESS ASSURANCE Sec. 1601. Findings. 1602. Definitions. 1603. General requirements; applicability; preemp- tion. 1604. Liability of biomaterials suppliers. 1605. Procedures for dismissal of civil actions against biomaterials suppliers. 1606. Subsequent impleader of dismissed biomate- rials supplier. § 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 inven- tion, development, improvement, and mainte- nance 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 spe- cifically 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 prod- ucts; (5) because small quantities of the raw mate- rials and component parts are used for medical devices, sales of raw materials and component parts for medical devices constitute an ex- tremely small portion of the overall market for the raw materials and component parts; (6) under the Federal Food, Drug, and Cos- metic 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 mate- rials and component parts suppliers do not de- sign, 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 sup- plied 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-enhanc- ing medical devices; (10) because other suppliers of the raw mate- rials and component parts in foreign nations are refusing to sell raw materials or compo- nent parts for use in manufacturing certain medical devices in the United States, the pros- pects 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 in- vestment 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 compo-