---
kind: "section"
citation: "21 U.S.C. § 1604"
title: "21"
title_heading: "Food and Drugs"
number: "1604"
heading: "Liability of biomaterials suppliers"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/1604"
units:
  - "Chapter 21 — Biomaterials Access Assurance"
---

# §1604. Liability of biomaterials suppliers

- (a) **In general—** Except as provided in [section 1606 of this title](/usc/21/1606.md), a [biomaterials supplier](/usc/21/1602.md?p=1-A) shall not be liable for harm to a [claimant](/usc/21/1602.md?p=2-A) caused by an [implant](/usc/21/1602.md?p=5) unless such supplier is liable—
  - (1) as a [manufacturer](/usc/21/1602.md?p=6) of the [implant](/usc/21/1602.md?p=5), as provided in [subsection (b)](#b);
  - (2) as a [seller](/usc/21/1602.md?p=10-A) of the [implant](/usc/21/1602.md?p=5), as provided in [subsection (c)](#c); or
  - (3) for furnishing [raw materials](/usc/21/1602.md?p=8) or [component parts](/usc/21/1602.md?p=3-A) for the [implant](/usc/21/1602.md?p=5) that failed to meet applicable contractual requirements or specifications, as provided in [subsection (d)](#d).
- (b) **Liability as manufacturer—**
  - (1) **In general—** A [biomaterials supplier](/usc/21/1602.md?p=1-A) may, to the extent required and permitted by any other applicable law, be liable for harm to a [claimant](/usc/21/1602.md?p=2-A) caused by an [implant](/usc/21/1602.md?p=5) if the [biomaterials supplier](/usc/21/1602.md?p=1-A) is the [manufacturer](/usc/21/1602.md?p=6) of the [implant](/usc/21/1602.md?p=5).
  - (2) **Grounds for liability—** The [biomaterials supplier](/usc/21/1602.md?p=1-A) may be considered the [manufacturer](/usc/21/1602.md?p=6) of the [implant](/usc/21/1602.md?p=5) that allegedly caused harm to a [claimant](/usc/21/1602.md?p=2-A) only if the [biomaterials supplier](/usc/21/1602.md?p=1-A)—
    - (A)
      - (i) registered or was required to register with the [Secretary](/usc/21/1602.md?p=9) pursuant to [section 360 of this title](/usc/21/360.md) and the regulations issued under such section; and
      - (ii) included or was required to include the [implant](/usc/21/1602.md?p=5) on a list of devices filed with the [Secretary](/usc/21/1602.md?p=9) pursuant to [section 360(j) of this title](/usc/21/360.md?p=j) and the regulations issued under such section;
    - (B) is the subject of a declaration issued by the [Secretary](/usc/21/1602.md?p=9) pursuant to [paragraph (3)](#b-3) that states that the supplier, with respect to the [implant](/usc/21/1602.md?p=5) that allegedly caused harm to the [claimant](/usc/21/1602.md?p=2-A), was required to—
      - (i) register with the [Secretary](/usc/21/1602.md?p=9) under [section 360 of this title](/usc/21/360.md), and the regulations issued under such section, but failed to do so; or
      - (ii) include the [implant](/usc/21/1602.md?p=5) on a list of devices filed with the [Secretary](/usc/21/1602.md?p=9) pursuant to [section 360(j) of this title](/usc/21/360.md?p=j) and the regulations issued under such section, but failed to do so; or
    - (C) is related by common ownership or control to a person meeting all the requirements described in subparagraph [(A)](#b-2-A) or [(B)](#b-2-B), if the court deciding a motion to dismiss in accordance with [section 1605(c)(3)(B)(i) of this title](/usc/21/1605.md?p=c-3-B-i) finds, on the basis of affidavits submitted in accordance with [section 1605 of this title](/usc/21/1605.md), that it is necessary to impose liability on the [biomaterials supplier](/usc/21/1602.md?p=1-A) as a [manufacturer](/usc/21/1602.md?p=6) because the related [manufacturer](/usc/21/1602.md?p=6) meeting the requirements of subparagraph [(A)](#b-2-A) or [(B)](#b-2-B) lacks sufficient financial resources to satisfy any judgment that the court feels it is likely to enter should the [claimant](/usc/21/1602.md?p=2-A) prevail.
  - (3) **Administrative procedures—**
    - (A) **In general—** The [Secretary](/usc/21/1602.md?p=9) may issue a declaration described in [paragraph (2)(B)](#b-2-B) on the motion of the [Secretary](/usc/21/1602.md?p=9) or on petition by any person, after providing—
      - (i) notice to the affected persons; and
      - (ii) an opportunity for an informal hearing.
    - (B) **Docketing and final decision—** Immediately upon receipt of a petition filed pursuant to this paragraph, the [Secretary](/usc/21/1602.md?p=9) shall docket the petition. Not later than 120 days after the petition is filed, the [Secretary](/usc/21/1602.md?p=9) shall issue a final decision on the petition.
    - (C) **Applicability of statute of limitations—** Any applicable statute of limitations shall toll during the period from the time a [claimant](/usc/21/1602.md?p=2-A) files a petition with the [Secretary](/usc/21/1602.md?p=9) under this paragraph until such time as either (i) the [Secretary](/usc/21/1602.md?p=9) issues a final decision on the petition, or (ii) the petition is withdrawn.
    - (D) **Stay pending petition for declaration—** If a [claimant](/usc/21/1602.md?p=2-A) has filed a petition for a declaration with respect to a defendant, and the [Secretary](/usc/21/1602.md?p=9) has not issued a final decision on the petition, the court shall stay all proceedings with respect to that defendant until such time as the [Secretary](/usc/21/1602.md?p=9) has issued a final decision on the petition.
- (c) **Liability as seller—** A [biomaterials supplier](/usc/21/1602.md?p=1-A) may, to the extent required and permitted by any other applicable law, be liable as a [seller](/usc/21/1602.md?p=10-A) for harm to a [claimant](/usc/21/1602.md?p=2-A) caused by an [implant](/usc/21/1602.md?p=5) only if—
  - (1) the [biomaterials supplier](/usc/21/1602.md?p=1-A)—
    - (A) held title to the [implant](/usc/21/1602.md?p=5) and then acted as a [seller](/usc/21/1602.md?p=10-A) of the [implant](/usc/21/1602.md?p=5) after its initial sale by the [manufacturer](/usc/21/1602.md?p=6); or
    - (B) acted under contract as a [seller](/usc/21/1602.md?p=10-A) to arrange for the transfer of the [implant](/usc/21/1602.md?p=5) directly to the [claimant](/usc/21/1602.md?p=2-A) after the initial sale by the [manufacturer](/usc/21/1602.md?p=6) of the [implant](/usc/21/1602.md?p=5); or
  - (2) the [biomaterials supplier](/usc/21/1602.md?p=1-A) is related by common ownership or control to a person meeting all the requirements described in [paragraph (1)](#c-1), if a court deciding a motion to dismiss in accordance with [section 1605(c)(3)(B)(ii) of this title](/usc/21/1605.md?p=c-3-B-ii) finds, on the basis of affidavits submitted in accordance with [section 1605 of this title](/usc/21/1605.md), that it is necessary to impose liability on the [biomaterials supplier](/usc/21/1602.md?p=1-A) as a [seller](/usc/21/1602.md?p=10-A) because the related [seller](/usc/21/1602.md?p=10-A) meeting the requirements of [paragraph (1)](#c-1) lacks sufficient financial resources to satisfy any judgment that the court feels it is likely to enter should the [claimant](/usc/21/1602.md?p=2-A) prevail.
- (d) **Liability for failure to meet applicable contractual requirements or specifications—** A [biomaterials supplier](/usc/21/1602.md?p=1-A) may, to the extent required and permitted by any other applicable law, be liable for harm to a [claimant](/usc/21/1602.md?p=2-A) caused by an [implant](/usc/21/1602.md?p=5) if the [claimant](/usc/21/1602.md?p=2-A) in an action shows, by a preponderance of the evidence, that—
  - (1) the [biomaterials supplier](/usc/21/1602.md?p=1-A) supplied [raw materials](/usc/21/1602.md?p=8) or [component parts](/usc/21/1602.md?p=3-A) for use in the [implant](/usc/21/1602.md?p=5) that either—
    - (A) did not constitute the product described in the contract between the [biomaterials supplier](/usc/21/1602.md?p=1-A) and the person who contracted for the supplying of the product; or
    - (B) failed to meet any specifications that were—
      - (i) accepted, pursuant to applicable law, by the [biomaterials supplier](/usc/21/1602.md?p=1-A);
      - (ii) published by the [biomaterials supplier](/usc/21/1602.md?p=1-A);
      - (iii) provided by the [biomaterials supplier](/usc/21/1602.md?p=1-A) to the person who contracted for such product;
      - (iv) contained in a master file that was submitted by the [biomaterials supplier](/usc/21/1602.md?p=1-A) to the [Secretary](/usc/21/1602.md?p=9) and that is currently maintained by the [biomaterials supplier](/usc/21/1602.md?p=1-A) for purposes of premarket approval of [medical devices](/usc/21/1602.md?p=7); or
      - (v) included in the submissions for purposes of premarket approval or review by the [Secretary](/usc/21/1602.md?p=9) under section [360](/usc/21/360.md), [360c](/usc/21/360c.md), [360e](/usc/21/360e.md), or [360j](/usc/21/360j.md) of this title, and received clearance from the [Secretary](/usc/21/1602.md?p=9) if such specifications were accepted, pursuant to applicable law, by the [biomaterials supplier](/usc/21/1602.md?p=1-A); and
  - (2) such failure to meet applicable contractual requirements or specifications was an actual and proximate cause of the harm to the [claimant](/usc/21/1602.md?p=2-A).

## Source credit

(Pub. L. 105–230, § 5, Aug. 13, 1998, 112 Stat. 1524.)

## Notes

### 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.