Statutory Defense for Manufacturers of Components Parts of Medical Devices


[author: Soo Kim]

In 1998, Congress enacted the Biomaterials Access Assurance Act (“BAAA” or “the statute”), which shields certain companies from product liability suits.  See 21 U.S.C. §§ 1601, et seq.  The statute’s protections are granted to companies that supply component parts and/or raw materials used in the manufacture of implantable medical devices and permits qualifying companies to avoid costly litigation expenses by filing motions to dismiss prior to commencement of discovery.  General highlights of the statute include:

Who Is Covered Under BAAA?

Biomaterials suppliers generally are shielded from liability in product liability suits.  The BAAA defines the biomaterials supplier as an entity that “directly or indirectly supplies a component part or raw material for use in the manufacture of an implant.”  21 U.S.C. § 1602(1)(A).  Generally, manufacturers and sellers of the finished medical device are not covered by the BAAA.  21 U.S.C. § 1604(b), (c)

What Is the Benefit of BAAA?

The statute creates a streamlined procedural process for qualifying biomaterials suppliers to seek dismissal with minimal litigation costs.  21 U.S.C. § 1601(15)(A)-(B).  Namely, the statute does not permit discovery of the biomaterials supplier and evidence in support of the motion to dismiss may be made by affidavit.  21 U.S.C. 1605(c).


The protections afforded by the statute apply to all civil suits for personal injury brought in federal or state courts, and expressly preempts state law.  21 U.S.C. § 1603(b),(c).

How to Obtain BAAA Dismissal

A biomaterials supplier may seek a dismissal by filing a FRCP 12(b)(6) motion to dismiss or by filing a motion for summary judgment.  The motion must be based on the grounds that the biomaterials supplier is exempt from liability, further that it is not the manufacturer or seller of the implant, that the raw materials or component parts met applicable contractual requirements or specifications, and that the manufacturer of the implant is also named as a party.  See 21 U.S.C. 1605.




The BAAA provides important protection against needless and costly litigation for covered entities.  While many state jurisdictions generally recognize a bulk supplier or raw materials defense, the BAAA affords the biomaterials supplier with important benefits – obtaining a dismissal from a personal injury action prior to discovery while limiting litigation costs to preparing affidavits in support of the motion to dismiss.  In the event of a lawsuit, companies that manufacture component parts and/or supply the raw material for implantable medical devices should refer to the BAAA to determine whether the statute applies.


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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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