§1604 Liability of biomaterials suppliers

Summary

Biomaterials suppliers are usually not responsible for harm from an implanted medical device unless one of three things is true. They can be held responsible if they are treated as the implant’s manufacturer, if they acted as a seller after the first sale, or if they supplied raw materials or parts that did not meet required contract terms or specifications and that failure caused the injury. If someone asks the Secretary for a formal finding about whether a supplier should be treated as a manufacturer, the Secretary must give notice, offer an informal hearing, put the petition on the docket, and issue a final decision within 120 days. While that petition is pending, time limits for filing claims are paused and court cases against that supplier are put on hold. Definitions in simple terms: Manufacturer — a supplier is treated as the manufacturer only if it was registered and had the device listed with the FDA, or the Secretary finds it should have registered or listed but did not, or if a related company that meets those rules lacks money and a court, based on sworn statements, decides it’s necessary to hold the supplier liable. Seller — a supplier who kept title and sold the implant after the first sale, or who arranged a direct transfer to the patient under contract, or a related company if a court finds that necessary. Raw materials or parts supplier — a supplier who provided materials that did not match the contract or accepted specifications (including things the supplier published, gave to the buyer, kept in an FDA master file, or included in FDA submissions) and whose failure was more likely than not the direct cause of the harm.