Biomaterials Access Assurance Act of 1998 is a United States federal statute establishing liability exemptions for biomaterial suppliers selling chemical components and raw materials utilized in implantable devices for human recipients. The United States federal legislation sets forth rules limiting litigation costs or unwarranted lawsuits for biomaterial suppliers excluded from the design, production, and testing of implantable devices demonstrated as effective and safe to include adequate product warnings.

The H.R. 872 bill was passed by the 105th United States Congressional session and enacted into law by the 42nd President of the United States Bill Clinton on August 13, 1998.^[1]

The 1998 Act was compiled as six sections establishing liability rulings for biomaterial elements sold by domestic and international suppliers to healthcare manufacturers located in the continental United States.

21 U.S.C. § 1601 ~ U.S. Congressional findings

21 U.S.C. § 1602 ~ Definitions

21 U.S.C. § 1603 ~ General requirements, applicability, and preemption

21 U.S.C. § 1604 ~ Liability of biomaterials suppliers

21 U.S.C. § 1605 ~ Procedures for dismissal of civil actions against biomaterials suppliers

21 U.S.C. § 1606 ~ Subsequent impleader of dismissed biomaterials supplier

On January 31, 1995, the 104th United States House of Representatives and United States Senate introduced the initial liability exemption legislation for suppliers dealing in biomaterial bulk products.^[2][3]

Biocompatibility

Biomaterial Surface Modifications

Biopolymer

Mechanical properties of biomaterials

Medical Device Regulation Act

Surface modification of biomaterials with proteins