21 USC 1603 – General requirements; applicability; preemption
(a) General requirements
(1) In general
In any civil action covered by this chapter, a biomaterials supplier may—
(A) raise any exclusion from liability set forth in section 1604 of this title; and
(B) make a motion for dismissal or for summary judgment as set forth in section 1605 of this title.
(2) Procedures
Notwithstanding any other provision of law, a Federal or State court in which an action covered by this chapter is pending shall, in connection with a motion under section 1605 or 1606 of this title, use the procedures set forth in this chapter.
(b) Applicability
(1) In general
Except as provided in paragraph (2), this chapter applies to any civil action brought by a claimant, whether in a Federal or State court, on the basis of any legal theory, for harm allegedly caused, directly or indirectly, by an implant.
(2) Exclusion
A civil action brought by a purchaser of a medical device, purchased for use in providing professional health care services, for loss or damage to an implant or for commercial loss to the purchaser—
(A) shall not be considered an action that is subject to this chapter; and
(B) shall be governed by applicable commercial or contract law.
(c) Scope of preemption
(1) In general
This chapter supersedes any State law regarding recovery for harm caused by an implant and any rule of procedure applicable to a civil action to recover damages for such harm only to the extent that this chapter establishes a rule of law applicable to the recovery of such damages.
(2) Applicability of other laws
Any issue that arises under this chapter and that is not governed by a rule of law applicable to the recovery of damages described in paragraph (1) shall be governed by applicable Federal or State law.
(d) Statutory construction
Nothing in this chapter may be construed—
(1) to affect any defense available to a defendant under any other provisions of Federal or State law in an action alleging harm caused by an implant; or
(2) to create a cause of action or Federal court jurisdiction pursuant to section 1331 or 1337 of title 28 that otherwise would not exist under applicable Federal or State law.
Terms Used In 21 USC 1603
- biomaterials supplier: means an entity that directly or indirectly supplies a component part or raw material for use in the manufacture of an implant. See 21 USC 1602
- claimant: means any person who brings a civil action, or on whose behalf a civil action is brought, arising from harm allegedly caused directly or indirectly by an implant, including a person other than the individual into whose body, or in contact with whose blood or tissue, the implant is placed, who claims to have suffered harm as a result of the implant. See 21 USC 1602
- Contract: A legal written agreement that becomes binding when signed.
- Damages: Money paid by defendants to successful plaintiffs in civil cases to compensate the plaintiffs for their injuries.
- Defendant: In a civil suit, the person complained against; in a criminal case, the person accused of the crime.
- Dismissal: The dropping of a case by the judge without further consideration or hearing. Source:
- harm: means &mdash. See 21 USC 1602
- implant: means &mdash. See 21 USC 1602
- Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.
- medical device: means a device, as defined in section 321(h) of this title, and includes any device component of any combination product as that term is used in section 353(g) of this title. See 21 USC 1602
- State: means a State, the District of Columbia, the Commonwealth of Puerto Rico, or any other territory or possession of the United States. See 1 USC 7