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U.S. Code as of:
01/19/04
Section 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.
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