| Shorttitle: | Biomaterials Access Assurance Act of 1998 |
| Longtitle: | An Act to establish rules governing product liability actions against raw materials and bulk component suppliers to medical device manufacturers, and for other purposes. |
| Nickname: | Biomaterials Access Assurance Act of 1997 |
| Enacted By: | 105th |
| Effective Date: | August 13, 1998 |
| Public Law Url: | https://www.gpo.gov/fdsys/pkg/STATUTE-112/pdf/STATUTE-112-Pg1519.pdf |
| Cite Public Law: | 105–230 |
| Title Amended: | 21 U.S.C.: Food and Drugs |
| Sections Created: | § 1601 et seq. |
| Agenciesaffected: | Food and Drug Administration |
| Introducedin: | House |
| Introducedby: | George Gekas (R–PA) |
| Introduceddate: | February 27, 1997 |
| Committees: | House Judiciary, House Commerce |
| Passedbody1: | House |
| Passeddate1: | July 30, 1998 |
| Passedvote1: | Passed without objection |
| Passedbody2: | Senate |
| Passeddate2: | July 30, 1998 |
| Passedvote2: | Passed unanimous consent |
| Signedpresident: | William J. Clinton |
| Signeddate: | August 13, 1998 |
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]
Biomaterial Surface Modifications
Mechanical properties of biomaterials
Surface modification of biomaterials with proteins