---
kind: "section"
citation: "21 U.S.C. § 1601"
title: "21"
title_heading: "Food and Drugs"
number: "1601"
heading: "Findings"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/1601"
units:
  - "Chapter 21 — Biomaterials Access Assurance"
---

# §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](/usc/21/1602.md?p=7), many of which are permanently implantable within the human body;
- (2) a continued supply of [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A) is necessary for the invention, development, improvement, and maintenance of the supply of the devices;
- (3) most of the [medical devices](/usc/21/1602.md?p=7) are made with [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A) that—
  - (A) move in interstate commerce;
  - (B) are not designed or manufactured specifically for use in [medical devices](/usc/21/1602.md?p=7); and
  - (C) come in contact with internal human tissue;
- (4) the [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A) also are used in a variety of nonmedical products;
- (5) because small quantities of the [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A) are used for [medical devices](/usc/21/1602.md?p=7), sales of [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A) for [medical devices](/usc/21/1602.md?p=7) constitute an extremely small portion of the overall market for the [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A);
- (6) under the Federal Food, Drug, and Cosmetic Act ([21 U.S.C. 301](/usc/21/301.md) et seq.) [manufacturers](/usc/21/1602.md?p=6) of [medical devices](/usc/21/1602.md?p=7) are required to demonstrate that the [medical devices](/usc/21/1602.md?p=7) are safe and effective, including demonstrating that the products are properly designed and have adequate warnings or instructions;
- (7) notwithstanding the fact that [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A) suppliers do not design, produce, or test a final [medical device](/usc/21/1602.md?p=7), the suppliers have been the subject of actions alleging inadequate—
  - (A) design and testing of [medical devices](/usc/21/1602.md?p=7) manufactured with materials or parts supplied by the suppliers; or
  - (B) warnings related to the use of such [medical devices](/usc/21/1602.md?p=7);
- (8) even though suppliers of [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A) have very rarely been held liable in such actions, such suppliers have ceased supplying certain [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A) for use in [medical devices](/usc/21/1602.md?p=7) for a number of reasons, including concerns about the costs of such litigation;
- (9) unless alternate sources of supply can be found, the unavailability of [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A) for [medical devices](/usc/21/1602.md?p=7) will lead to unavailability of lifesaving and life-enhancing [medical devices](/usc/21/1602.md?p=7);
- (10) because other suppliers of the [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A) in foreign nations are refusing to sell [raw materials](/usc/21/1602.md?p=8) or [component parts](/usc/21/1602.md?p=3-A) for use in manufacturing certain [medical devices](/usc/21/1602.md?p=7) in the United States, the prospects for development of new sources of supply for the full range of threatened [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A) for [medical devices](/usc/21/1602.md?p=7) are remote;
- (11) it is unlikely that the small market for such [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A) in the United States could support the large investment needed to develop new suppliers of such [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A);
- (12) attempts to develop such new suppliers would raise the cost of [medical devices](/usc/21/1602.md?p=7);
- (13) courts that have considered the duties of the suppliers of the [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A) have generally found that the suppliers do not have a duty—
  - (A) to evaluate the safety and efficacy of the use of a [raw material](/usc/21/1602.md?p=8) or [component part](/usc/21/1602.md?p=3-A) in a [medical device](/usc/21/1602.md?p=7); or
  - (B) to warn consumers concerning the safety and effectiveness of a [medical device](/usc/21/1602.md?p=7);
- (14) because [medical devices](/usc/21/1602.md?p=7) and the [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A) used in their manufacture move in interstate commerce, a shortage of such [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A) affects interstate commerce;
- (15) in order to safeguard the availability of a wide variety of lifesaving and life-enhancing [medical devices](/usc/21/1602.md?p=7), immediate action is needed—
  - (A) to clarify the permissible bases of liability for suppliers of [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A) for [medical devices](/usc/21/1602.md?p=7); and
  - (B) to provide expeditious procedures to dispose of unwarranted suits against the suppliers in such manner as to minimize litigation costs;
- (16) the several States and their courts are the primary architects and regulators of our tort system; Congress, however, must, in certain circumstances involving the national interest, address tort issues, and a threatened shortage of [raw materials](/usc/21/1602.md?p=8) and [component parts](/usc/21/1602.md?p=3-A) for lifesaving [medical devices](/usc/21/1602.md?p=7) is one such circumstance; and
- (17) the protections set forth in this chapter are needed to assure the continued supply of materials for lifesaving [medical devices](/usc/21/1602.md?p=7), although such protections do not protect negligent suppliers.

## Source credit

(Pub. L. 105–230, § 2, Aug. 13, 1998, 112 Stat. 1519.)

## Notes

### Editorial Notes

### References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in par. (6), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

### Statutory Notes and Related Subsidiaries

### Effective Date

Pub. L. 105–230, § 8, Aug. 13, 1998, 112 Stat. 1529, provided that: “This Act [enacting this chapter] shall apply to all civil actions covered under this Act that are commenced on or after the date of enactment of this Act [Aug. 13, 1998], including any such action with respect to which the harm asserted in the action or the conduct that caused the harm occurred before the date of enactment of this Act.”

### Short Title

Pub. L. 105–230, § 1, Aug. 13, 1998, 112 Stat. 1519, provided that: “This Act [enacting this chapter] may be cited as the ‘Biomaterials Access Assurance Act of 1998’.”