The Biomaterials Access Assurance Act of 1998 is a critical piece of legislation for raw materials suppliers. However, it is also key that device manufacturers understand how the law works. A blog from Beck and Herrmann sheds some light on this often forgotten rule.
As they describe it, BAAA creates immunity for companies that provide biomaterials that are used to manufacture implantable medical devices. The manufacturer of the device itself may be liable, of course, but the company that provided raw materials or component parts generally is not.
I encourage my readers to check out the lawyers’ interpretation of the Biomaterials Act. A little refresher never hurts.
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December 9th, 2008
