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| Long title | An Act to establish rules governing product liability actions against raw materials and bulk component suppliers to medical device manufacturers, and for other purposes. |
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| Nicknames | Biomaterials Access Assurance Act of 1997 |
| Enacted by | the 105th United States Congress |
| Effective | August 13, 1998 |
| Citations | |
| Public law | 105–230 |
| Statutes at Large | 112 Stat. 1519 |
| Codification | |
| Titles amended | 21 U.S.C.: Food and Drugs |
| U.S.C. sections created | 21 U.S.C. ch. 21 § 1601 et seq. |
| Legislative history | |
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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.
Provision of the Act
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
Legislation of 1995
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.
See also
- Biocompatibility
- Biomaterial Surface Modifications
- Biopolymer
- Mechanical properties of biomaterials
- Medical Device Regulation Act
- Surface modification of biomaterials with proteins
External links
- "Implementation of the Biomaterials Access Assurance Act of 1998". U.S. Food and Drug Administration. U.S. Department of Health and Human Services. April 2, 2001.
- "Society For Biomaterials". Society For Biomaterials ~ SFB. Association Headquarters.
- "The Biomaterials Access Assurance Act of 1998 and Supplier Liability: Who You Gonna Sue?" (PDF). The Delaware Journal of Corporate Law.