Title 21 of the U.S. Code § 1603 - General requirements; applicability; preemption
Full text of § 1603 from Title 21 of the United States Code.
§ 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.
(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 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.
About This Section
21 U.S.C. § 1603 is part of Title 21 of the United States Code. The United States Code is the official codification of federal statutes maintained by the Office of the Law Revision Counsel of the U.S. House of Representatives. Congress amends the Code through new public laws, which are eventually incorporated into the relevant title.
This section may be cited in legal writing as 21 U.S.C. § 1603. For the most current official text, including any recent amendments, use the official source links below. Do not rely on this page as the sole authority for legal citation or litigation.
How to Read This Statute
Statutes are organized by title, chapter, section, and subsection. Pay attention to words like "shall," "may," "and," and "or," because they determine whether a requirement is mandatory or permissive and whether multiple conditions must all be met. Historical notes and amendments often appear at the end of a section.
Using This Page
This page is intended for research and educational use. Lawyers, students, journalists, and compliance professionals can use it as a starting point, but should always verify the current text through an official government source before relying on it for legal advice, filings, or compliance decisions.