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United States · Bill · S

S. 966 (105th)

Biomaterials Access Assurance Act of 1997

referredUnited States· United States Congress· EN

Introduced

26 June 1997

Last action

Status

Read twice and referred to the Committee on Commerce.

Sponsors

Subjects

Discovery layer

Source updated

21 August 2025

Summary

Biomaterials Access Assurance Act of 1997 - Provides that, in any civil action, a biomaterials supplier (one who supplies components or raw materials used to manufacture implants) may raise any defense provided under this Act. (Sec. 5) Exempts a biomaterials supplier from liability for harm to a claimant caused by an implant, with exceptions in the case of a supplier who: (1) is a registered manufacturer of the implant; (2) is a seller of the implant and who held title to the implant at the time of sale (or is related by common ownership or control to such a seller); (3) furnishes raw materials or components that fail to meet applicable contractual requirements or specifications; (4) knew, or through reasonable inquiry could have known, of the application to which the raw material was to be put, the risks, and that the buyer or user was ignorant of the risks, but failed to warn the buyer or user; or (5) furnished raw materials that were defective. Declares that a supplier may be considered a manufacturer of an implant, for purposes of such civil actions, only if the supplier has registered with the Secretary of Health and Human Services and included the implant on a list of devices filed pursuant to the Federal Food, Drug, and Cosmetic Act. (Sec. 6) Sets forth procedures regarding dismissal of actions against suppliers. Requires claimant payment of attorney's fees if the court finds the claim to be without merit and frivolous.

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3 official files

Introduced in Senate (text)

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