Title 21 › CHAPTER 21 — BIOMATERIALS ACCESS ASSURANCE › § 1603
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
Food and Drugs, Source: USLM XML via OLRC
Legislative History
Reference
Citation
21 U.S.C. § 1603
Title 21, Food and Drugs
Last Updated
Sep 22, 2026
Release point: 119-110