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21 USC § 1603 - General requirements; applicability; preemption

---
identifier: "/us/usc/t21/s1603"
source: "usc"
legal_status: "official_prima_facie"
title: "21 USC § 1603 - General requirements; applicability; preemption"
title_number: 21
title_name: "FOOD AND DRUGS"
section_number: "1603"
section_name: "General requirements; applicability; preemption"
chapter_number: 21
chapter_name: "BIOMATERIALS ACCESS ASSURANCE"
positive_law: false
currency: "119-84"
last_updated: "2026-04-17"
format_version: "1.1.0"
generator: "[email protected]"
source_credit: "(Pub. L. 105–230, § 4, Aug. 13, 1998, 112 Stat. 1523.)"
---

# § 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.

---

**Source Credit**: (Pub. L. 105–230, § 4, Aug. 13, 1998, 112 Stat. 1523.)

## Statutory Notes and Related Subsidiaries

### Effective Date

Section applicable to all civil actions covered under this chapter commenced on or after , including any in which the harm or harmful conduct occurred before such date, see , set out as a note under .