Biomaterials Access Assurance Act of 1998

Biomaterials Access Assurance Act of 1998

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.
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
Introduced in the House as H.R. 872 by George Gekas (R–PA) on February 27, 1997 Committee consideration by House Judiciary, House Commerce Passed the House on July 30, 1998 (Passed without objection) Passed the Senate on July 30, 1998 (Passed unanimous consent) Signed into law by President William J. Clinton on August 13, 1998

Biomaterials Access Assurance Act of 1998 is an 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]

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.^[2][3]

See also

Biocompatibility

Biomaterial Surface Modifications

Biopolymer

Mechanical properties of biomaterials

Medical Device Regulation Act

Surface modification of biomaterials with proteins

References

1. Peters, Gerhard; Woolley, John T. "William J. Clinton: "Statement on Signing the Biomaterials Access Assurance Act of 1998," August 13, 1998". The American Presidency Project. University of California - Santa Barbara.
2. "H.R. 753 ~ Biomaterials Access Assurance Act of 1995". Congress.gov. January 31, 1995.
3. "S. 303 ~ Biomaterials Access Assurance Act of 1995". Congress.gov. January 31, 1995.

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.