Title 21, Food and DrugsRelease 119-110

§1603 General Requirements; Applicability; Preemption

Title 21 › CHAPTER 21 — BIOMATERIALS ACCESS ASSURANCE › § 1603

Last updated Sep 22, 2026|Official source

Summary

Gives biomaterials suppliers in covered civil cases the right to use the liability exclusions in section 1604 and to ask a court to dismiss or enter summary judgment under section 1605. If someone files a motion under section 1605 or 1606, the federal or state court must follow the procedures in this chapter. Applies to any lawsuit by a person who sues, in Federal or State court, for harm caused directly or indirectly by an implant, no matter the legal theory. It does not apply when a buyer of a medical device bought for providing professional health care sues for damage to the implant or for commercial loss; those suits follow commercial or contract law. The chapter replaces State law only where it sets rules for recovering damages. Other questions use the usual Federal or State law. Nothing here removes other defenses or creates federal jurisdiction under 28 U.S.C. 1331 or 1337 that did not already exist.

Full Legal Text

Title 21, §1603

Food and Drugs, Source: USLM XML via OLRC

(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.

Legislative History

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Effective Date

Section applicable to all civil actions covered under this chapter commenced on or after Aug. 13, 1998, including any in which the harm or harmful conduct occurred before such date, see section 8 of Pub. L. 105–230, set out as a note under section 1601 of this title.

Reference

Citations & Metadata

Citation

21 U.S.C. § 1603

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110