To establish rules governing product liability actions against raw materials and bulk component suppliers to. .
To establish rules governing product liability actions against raw materials and bulk component suppliers to medical device manufacturers, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, Section 1. short title. 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-.
An Act to establish rules governing product liability actions against raw materials and bulk component suppliers to medical device manufacturers, and for other purposes.
13, 1998 bulk component suppliers to medical device manufacturers, and for other purposes.
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The United States has well-developed product liability laws . No uniform product liability statute or common law exists in the United States – each state defines product liability law under its own standards. However, product liability claims are generally brought under the scope of strict product, tort (negligence or fraud) and warranty. Further, most states have a version of a deceptive trade practices act or consumer protection statute. Typically, these laws proscribe certain types of sale and marketing practice as unconscionable or deceptive.
Typically, medical device manufacturers must rely on components and raw materials manufactured by other .
While some implants, for instance those used in reconstructive plastic surgery, consist of a single, homogeneous material, the majority of devices integrate a broad range of technologies. In many instances these components are produced for other commercial applications but have also been qualified for use in medical applications. The dilemma that exists for the raw material or component supplier can be illustrated by the following example.
MODEL LEGISLATION NEWS Product Liability Act Summary ALEC EXPOSED The Product Liability Act .
MODEL LEGISLATION NEWS Product Liability Act Summary ALEC EXPOSED The Product Liability Act adopts defenses to absolute liability, including defenses based upon misuse or alteration, state of the art at time of manufacture, compliance with government standards, inherent characteristics known to the ordinary person, unavoidably dangerous products, and provision of a warning to an appropriate third party
Last year Congress passed legislation protecting suppliers of bulk .
Last year Congress passed legislation protecting suppliers of bulk components and raw materials for implants from lawsuits. The BAAA applies to all implant raw materials and components except the silicone gel and the silicone envelope utilized in a breast implant containing silicone gel. The new law supersedes otherwise applicable state laws and procedures by precluding any civil action, regardless of the legal theory upon which it is based, for harm, other than commercial loss or loss of or damage to an implant, caused by an implant.