Last edited by Shaktigar
Friday, November 13, 2020 | History

3 edition of Biomaterials Access Assurance Act of 1998 found in the catalog.

Biomaterials Access Assurance Act of 1998

United States. Congress. House. Committee on the Judiciary

Biomaterials Access Assurance Act of 1998

report together with dissenting views (to accompany H.R. 872) (including cost estimate of the Congressional Budget Office).

by United States. Congress. House. Committee on the Judiciary

  • 57 Want to read
  • 29 Currently reading

Published by U.S. G.P.O. in [Washington, D.C .
Written in English

    Subjects:
  • Products liability -- Medical instruments and apparatus -- United States.,
  • Raw materials -- Law and legislation -- United States.

  • Edition Notes

    SeriesRept. / 105th Congress, 2d session, House of Representatives -- 105-549.
    The Physical Object
    Paginationv. ;
    ID Numbers
    Open LibraryOL15497021M

    By making research easy to access, and puts the academic needs of the researchers before the business interests of publishers. Our authors and editors We are a community of more than , authors and editors from 3, institutions spanning countries, including Nobel Prize winners and some of the world’s most-cited researchers.   () Examples include childhood vaccines, National Childhood Vaccine Injury Act of , P.L. ; small aircraft, General Aviation Revitalization Act, P.L. ; and materials used in implantable medical devices, Biomaterials Access Assurance Act of , P.L.


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Biomaterials Access Assurance Act of 1998 by United States. Congress. House. Committee on the Judiciary Download PDF EPUB FB2

Biomaterials Access Assurance Act of Public Law th Congress An Act To establish rules governing product liability actions against raw materials and bulk component suppliers to medical device manufacturers, and for other purposes. - [H.R.

]>>. And sometimes they are meant to garner political support for a law by giving it a catchy name (as with the 'USA Patriot Act' or the 'Take Pride in America Act') or by invoking public outrage or sympathy (as with any number of laws named for victims of crimes).

History books, newspapers, and other sources use the popular name to refer to these laws. (The full cite is The Biomaterials Access Assurance Act of21 U.S.C.

Secs. ) InCongress was concerned that suppliers of raw materials were being unfairly targeted in litigation. The Biomaterials Access Assurance Act of (BAAA) was enacted with the aim of preventing suppliers, such as DuPont, from becoming entangled in this type of product liability litigation. This note explores the legitimacy of BAAA and the relative impact it may have on businesses that supply raw materials or component parts to medical device Author: Anne Marie Murphy.

Biomaterials Access Assurance Act of Hearing before the Subcommittee on Commercial and Administrative Law of the Committee on the Judiciary, first session, on H.R.

J [United States] on *FREE* shipping on qualifying offers. Biomaterials Access Assurance Act of Hearing before the Subcommittee on Commercial and Administrative Law of the. 2, at 11 ()). Another report exempli-fied the problem with the case of DuPont, a company that supplied Teflon to Vitek, a By James F.

Murdica and Jenya Moshkovich The Biomaterials Access Assurance Act can be a valuable tool to protect biomedical suppliers from baseless civil suits. The Biomaterials Access Assurance Act (BAAA) was. REPEAL THE BIOMATERIALS ACCESS ASSURANCE ACT OF ’ We, the undersigned, call on the United States House of Representatives to consider repealing the Biomaterials Access Assurance Act of and hold any supplier of raw material such as Dacron, Polytetrafluoroethylene (Teflon), and Polypropylene liable if they knowingly provide said.

Get this from a library. Biomaterials Access Assurance Act of 1998 book Access Assurance Act of hearing Biomaterials Access Assurance Act of 1998 book the Subcommittee on Commercial and Administrative Law of the Committee on the Judiciary, House of Representatives, One Hundred Fifth Congress, first session, on H.R.

J [United States. Congress. House. Committee on the Judiciary. 21 U.S. Code CHAPTER 21— BIOMATERIALS ACCESS ASSURANCE. U.S. Code ; Notes ; prev | next § Findings § Definitions § General requirements; applicability; preemption Procedures for dismissal of civil actions against biomaterials suppliers § Subsequent impleader of dismissed biomaterials supplier; U.S.

Code Toolbox. The Biomaterials Access Assurance Act of effectively insulates biomaterials suppliers from liability when their raw materials or component parts are used in implanted medical devices. As set forth within the terms of the act, its protection may be invoked within the course of litigation by various means.

The Biomaterials Access Assurance Act of (BAAA) was enacted with the aim of preventing suppliers, such as DuPont, from becoming entangled in this type of product liability : Anne Marie Murphy. The ''Biomaterials Access Assurance Act of '' is designed to help ensure the continued availability of implantable medical devices by protecting suppliers against high litigation costs, without affecting in any way the liability that device manufacturers face under existing law.

This measure enjoys wide support, and HIMA hopes that, with. Get this from a library. Biomaterials Access Assurance Act of report together with dissenting views (to accompany H.R.

) (including cost estimate of the Congressional Budget Office). [United States. Congress. House. Committee on the Judiciary.; United States. Congress.

House. Committee on. This book provides tabular and text data relating to normal and diseased tissue materials and materials used in medical devices. Comprehensive and practical for students, researchers, engineers, and practicing physicians who use implants, this book considers the materials aspects of both.

Biomaterials Access Assurance Act of 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.

Biomaterials Access Assurance Act of 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.

Purpose and Summary H.R.the ``Biomaterials Access Assurance Act of '' is designed to ensure American patients' access to medical implants and devices.

To foster medical device access, the bill would protect the suppliers of raw materials and component parts for such devices from much of the costs of discovery and defense in lawsuits.

We’ve blogged several times about the Biomaterials Access Assurance Act of21 U.S.C. §§ In a nutshell, the BAAA provides. H.R.Biomaterials Access Assurance Act of J Cost Estimate.

Cost estimate for the bill as ordered reported by the House Committee on Commerce on J View Document KB. Summary.

BOOKS; PODCASTS; EVENTS; LINKS. Blogroll "The Biomaterials Access Assurance Act of " By Walter Olson on December 5, AM. Tweet. There's surprisingly little good discussion online about this noteworthy if narrow piece of federal liability-reform legislation, as I found when trying to research it a while back.

H.R.Biomaterials Access Assurance Act of Ap Cost Estimate. Cost estimate for the bill as ordered reported by the House Committee on the Judiciary on April 1, View Document9 KB. Summary. U.S. Congress found it necessary to provide manufacturers of biomaterials—component parts or raw materials for implantable medical devices—protection from liability in litigation involving the.

In order to receive a copy of the draft guidance entitled ``Implementation of the Biomaterials Access Assurance Act of '' via your fax machine, call the CDRH Facts-On-Demand system at or from a touch-tone telephone.

Press 1 to enter the system. At the second voice prompt press 1 to order a document. The Biomaterials Access Assurance Act of Walter CF, Richards EP. IEEE Eng Med Biol Mag, 18(2), 01 Mar Cited by: 0 articles | PMID: Patent issue: supplier liability in medical implants and devices: the "Biomaterials Access Assurance Act".

Pabst PL, Mills KV Author: Amy Melnick. New Budget Authority, Entitlement Authority, and Tax Expenditures In compliance with clause 2(l)(3)(B) of rule XI of the Rules of the House of Representatives, the Committee finds that H.Rthe Biomaterials Access Assurance Act ofwould result in no new or increased budget authority, entitlement authority, or tax expenditures or revenues.

We’ve blogged several times about the Biomaterials Access Assurance Act of21 U.S.C. §§ In a nutshell, the BAAA provides suppliers of “raw materials and component parts” used in the manufacture of medical devices with a “Get Out of Litigation Free” card in most situations.

In response to this situation, the US congress introduced the Biomaterials Access Assurance Act in July to provide some protection to biomaterial manufacturers who simply act as suppliers of the biomaterial and to encourage the development of new by: (11) Implementation of the Biomaterials Access Assurance Act of ; Draft Guidance for Industry and FDA OC 04/02/ (12) Alternative to Certain Prescription Device Labeling Requirements OC 01/21/ (13) Civil Money Penalty Policy OC 06/08/ Biomaterials are an indispensable element in improving human health and quality of life.

Applications of biomaterials include diagnostics (gene arrays and biosensors), medical supplies (blood bags and surgical tools), therapeutic treatments (medical implants and devices), and emerging regenerative medicine (tissue-engineered skin and cartilage). We, the undersigned, call on the United States House of Representatives to consider repealing the Biomaterials Access Assurance Act of and hold any supplier of raw material such as Dacron, Polytetrafluoroethylene (Teflon), and Polypropylene liable if they knowingly provide said material to a medical device company that does not intend to use the material to manufacture a medically.

Biomaterials Access Assurance Act (Act) is a federal legislation that gives companies that provide biomaterials that are used to manufacture implantable medical devices immunity.

The Act also creates a procedural device to let a biomaterial supplier escape with reasonable cost from litigation aimed primarily at an implant manufacturer. U.S. Congress found it necessary to provide manufacturers of biomaterials—component parts or raw materials for implantable medical devices—protection from liability in litigation involving the manufacture and use of an implantable medical device under the Biomaterials Access Assurance Act (BAAA).

In order to receive a copy of the draft guidance entitled “Implementation of the Biomaterials Access Assurance Act of ” via your fax machine, call the CDRH Facts-On-Demand system at or from a touch-tone telephone.

Press 1 to enter the system. At the second voice prompt press 1 to order a document. Purchase Regulatory Affairs for Biomaterials and Medical Devices - 1st Edition.

Print Book & E-Book. ISBNGold Open Access Subscription; Articles are freely available to both subscribers and the wider public with permitted reuse. Articles are made available to subscribers as well as developing countries and patient groups through our access programs.: An open access publication fee is payable by authors or their research funder.: No open access publication fee.

Pages in category " in the United States" The following 22 pages are in this category, out of 22 total. This list may not reflect recent changes (). "The Biomaterials Access Assurance Act of ," 18 IEEE Engineering In Medicine And Biology Magazine #2, (). "The Supreme Court Sets Standards for Engineering Expert Testimony," 18 IEEE Engineering In Medicine And Biology Magazine #6, From Title FOOD AND DRUGS.

TITLE FOOD AND DRUGS. Chap. Sec. Adulterated or Misbranded Foods or Drugs Federal Food, Drug, and Cosmetic Act. Poultry and Poultry Products Inspection. Manufacture of Narcotic Drugs [Repealed] Biomaterials Access Assurance.

National Drug Control Policy. Following debates on Capitol Hill, President Bill Clinton, in Augustsigned into law the Biomaterials Access Assurance Act, which provides liability protection to manufacturers that supply raw materials and components for making medical devices but are not involved in design, development, or other aspects of the end products.

U.S. Congress found it necessary to provide manufacturers of biomaterials—component parts or raw materials for implantable medical devices—protection from liability in litigation involving the manufacture and use of an implantable medical device under the Biomaterials Access Assurance Act (BAAA).

21 U.S.C. § et seq. One such law is the General Aviation Revitalization Act ofwhich helped prevent the demise of the entire civil aviation industry.(11) Another example is the Biomaterials Access Assurance Act ofwhich helped assure that manufacturers of medical devices could obtain the raw materials necessary to make their life saving equipment.(12).During its spring term, Congress passed the Volunteer Protection Act and considered but did not pass the Biomaterials Access Assurance Act of Jennise W.

Stubbs & Kelsey A. Copeland, Using the Biomaterials Access Assurance Act as a Sword and a Shield, Bloomberg BNA: Medical Devices Law & .