Title 21 USC reference

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE Sec. 1601 - Findings From the U.S. Government Publishing Office, www.gpo.gov §1601. Findings The Congress finds that— (1) each year millions of citizens of the United States depend on the availability of lifesaving or life-enhancing medical devices, many of which are permanently implantable within the human body; (2) a continued supply of raw materials and component parts is necessary for the invention, development, improvement, and maintenance of the supply of the devices; (3) most of the medical devices are made with raw materials and component parts that— (A) move in interstate commerce; (B) are not designed or manufactured specifically for use in medical devices; and (C) come in contact with internal human tissue; (4) the raw materials and component parts also are used in a variety of nonmedical products; (5) because small quantities of the raw materials and component parts are used for medical devices, sales of raw materials and component parts for medical devices constitute an extremely small portion of the overall…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE Sec. 1602 - Definitions From the U.S. Government Publishing Office, www.gpo.gov §1602. Definitions As used in this chapter: (1) Biomaterials supplier (A) In general The term "biomaterials supplier" means an entity that directly or indirectly supplies a component part or raw material for use in the manufacture of an implant. (B) Persons included Such term includes any person who— (i) has submitted master files to the Secretary for purposes of premarket approval of a medical device; or (ii) licenses a biomaterials supplier to produce component parts or raw materials. (2) Claimant (A) In general The term "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. (B) Action brought on behalf of an estate With respect to an action…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE Sec. 1603 - General requirements; applicability; preemption From the U.S. Government Publishing Office, www.gpo.gov §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…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE Sec. 1604 - Liability of biomaterials suppliers From the U.S. Government Publishing Office, www.gpo.gov §1604. Liability of biomaterials suppliers (a) In general Except as provided in section 1606 of this title, a biomaterials supplier shall not be liable for harm to a claimant caused by an implant unless such supplier is liable— (1) as a manufacturer of the implant, as provided in subsection (b); (2) as a seller of the implant, as provided in subsection (c); or (3) for furnishing raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications, as provided in subsection (d). (b) Liability as manufacturer (1) In general A biomaterials supplier may, to the extent required and permitted by any other applicable law, be liable for harm to a claimant caused by an implant if the biomaterials supplier is the manufacturer of the implant. (2) Grounds for liability The biomaterials supplier may be considered the manufacturer of the implant that allegedly caused harm to a claimant…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE Sec. 1605 - Procedures for dismissal of civil actions against biomaterials suppliers From the U.S. Government Publishing Office, www.gpo.gov §1605. Procedures for dismissal of civil actions against biomaterials suppliers (a) Motion to dismiss A defendant may, at any time during which a motion to dismiss may be filed under applicable law, move to dismiss an action against it on the grounds that the defendant is a biomaterials supplier and one or more of the following: (1) The defendant is not liable as a manufacturer, as provided in section 1604(b) of this title. (2) The defendant is not liable as a seller, as provided in section 1604(c) of this title. (3) The defendant is not liable for furnishing raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications, as provided in section 1604(d) of this title. (4) The claimant did not name the manufacturer as a party to the action, as provided in subsection (b). (b) Manufacturer of implant shall be named a party In any civil…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE Sec. 1606 - Subsequent impleader of dismissed biomaterials supplier From the U.S. Government Publishing Office, www.gpo.gov §1606. Subsequent impleader of dismissed biomaterials supplier (a) Impleading of dismissed defendant A court, upon motion by a manufacturer or a claimant within 90 days after entry of a final judgment in an action by the claimant against a manufacturer, and notwithstanding any otherwise applicable statute of limitations, may implead a biomaterials supplier who has been dismissed from the action pursuant to this chapter if— (1) the manufacturer has made an assertion, either in a motion or other pleading filed with the court or in an opening or closing statement at trial, or as part of a claim for contribution or indemnification, and the court finds based on the court's independent review of the evidence contained in the record of the action, that under applicable law— (A) the negligence or intentionally tortious conduct of the dismissed supplier was an actual and proximate cause of the harm to the…