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Biomaterials Access Assurance Act (Act) is a federal legislation that gives companies that provide biomaterials that are used to manufacture implantable medical devices immunity. The Act also creates a procedural device to let a biomaterial supplier escape with reasonable cost from litigation aimed primarily at an implant manufacturer. According to the Act, a supplier may be considered a manufacturer of an implant for purposes of civil actions, only if the supplier was registered or was required to register with the secretary of health and human services and included or was required to include the implant on a list of devices filed pursuant to the Federal Food, Drug, and Cosmetic Act.
According to 21 USCS § 1601, courts that have considered the duties of suppliers of raw materials and component parts have generally found that the suppliers do not have a duty:
1. to evaluate the safety and efficacy of the use of a raw material or component part in a medical device; or
2. to warn consumers concerning the safety and effectiveness of a medical device.p>