| 词条 | Biomaterials Access Assurance Act of 1998 |
| 释义 |
| shorttitle = Biomaterials Access Assurance Act of 1998 | othershorttitles = | 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. | colloquialacronym = | 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| cite public law = 105–230 | cite statutes at large = {{usstat|112|1519}} | acts amended = | acts repealed = | title amended = 21 U.S.C.: Food and Drugs | sections created = {{Usc-title-chap|21|21}} § 1601 et seq. | sections amended = | leghisturl = | introducedin = House | introducedbill = {{USBill|105|H.R.|872}} | 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 | passedas2 = | passeddate2 = July 30, 1998 | passedvote2 = Passed unanimous consent | conferencedate = | passedbody3 = | passeddate3 = | passedvote3 = | agreedbody3 = | agreeddate3 = | agreedvote3 = | agreedbody4 = | agreeddate4 = | agreedvote4 = | passedbody4 = | passeddate4 = | passedvote4 = | signedpresident = William J. Clinton | signeddate = August 13, 1998 | unsignedpresident = | unsigneddate = | vetoedpresident = | vetoeddate = | overriddenbody1 = | overriddendate1 = | overriddenvote1 = | overriddenbody2 = | overriddendate2 = | overriddenvote2 = | amendments = | SCOTUS cases = }} 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] Provision of the ActThe 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 1995On 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{{Commons category|Implants (medicine)}}Biocompatibility Biomaterial Surface Modifications Biopolymer Mechanical properties of biomaterials Medical Device Regulation Act Surface modification of biomaterials with proteins References1. ^{{cite web |url=http://www.presidency.ucsb.edu/ws/?pid=54777 |title=William J. Clinton: "Statement on Signing the Biomaterials Access Assurance Act of 1998," August 13, 1998 |author1=Peters, Gerhard |author2=Woolley, John T |work=The American Presidency Project |publisher=University of California - Santa Barbara}} 2. ^{{cite web |url=https://www.congress.gov/bill/104th-congress/house-bill/753 |title=H.R. 753 ~ Biomaterials Access Assurance Act of 1995 |date=January 31, 1995 |publisher=Congress.gov}} 3. ^{{cite web |url=https://www.congress.gov/bill/104th-congress/senate-bill/303 |title=S. 303 ~ Biomaterials Access Assurance Act of 1995 |date=January 31, 1995 |publisher=Congress.gov}} External links
7 : Acts of the 105th United States Congress|United States federal health legislation|Healthcare quality|1998 in law|1998 in the United States|Food and Drug Administration|Regulation of medical devices |
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