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S 364 105th Congress Senate

Biomaterials Access Assurance Act of 1997

Official title: A bill to provide legal standards and procedures for suppliers of raw materials and component parts for medical devices.

Introduced: June 9, 1997 See on congress.gov
Commerce Administrative procedureArtificial implantsBiomedical engineeringBiomedical materials
More subjectsShow fewer subjects
Civil procedureDepartment of Health and Human ServicesDiscovery (Law)Evidence (Law)Federal preemptionFrivolous lawsuitsGovernment Operations and PoliticsHealthLawLegal feesManufacturing industriesMedical suppliesParties to actionsProducts liabilityRaw materialsScience, Technology, CommunicationsState laws
This bill died when the 105th Congress ended
It never became law before the 105th Congress (1997–1998) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Feb 26, 1997
Read twice and referred to the Committee on Commerce.
Feb 26, 1997
Sponsor introductory remarks on measure. (CR S1672-1673, S1675-1676)
Feb 26, 1997
Introduced in Senate
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 Latest action February 26, 1997

Read twice and referred to the Committee on Commerce.

 Plain-English summary Congressional Research Service

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.

Exempts a biomaterials supplier (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 (3) furnishes raw materials or components that fail to meet applicable contractual requirements or specifications. Provides grounds for liability with respect to each exception. Outlines procedural guidelines for the dismissal of civil actions against suppliers . States 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. Requires claimant payment of attorney's fees if: (1 ) the claimant named or joined the biomaterials supplier; and (2) the court finds the claim to be without merit and frivolous.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
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APA
U.S. Congress. (2026). S. 364: Biomaterials Access Assurance Act of 1997. 105th Congress. Open America. https://openamerica.io/bill/105-S-364/
MLA
"S. 364: Biomaterials Access Assurance Act of 1997." 105th Congress, 2026, Open America, https://openamerica.io/bill/105-S-364/.
Bluebook (legal)
S. 364, 105th Cong. (2026), https://openamerica.io/bill/105-S-364/.
Markdown link
[S. 364: Biomaterials Access Assurance Act of 1997](https://openamerica.io/bill/105-S-364/)
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