---
kind: "section"
citation: "21 U.S.C. § 360bbb–8b"
title: "21"
title_heading: "Food and Drugs"
number: "360bbb–8b"
heading: "Use of clinical investigation data from outside the United States"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360bbb-8b"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part E — General Provisions Relating to Drugs and Devices"
---

# §360bbb–8b. Use of clinical investigation data from outside the United States

- (a) **In general—** In determining whether to approve, license, or clear a [drug](/usc/21/321.md?p=g-1), biological [product](/usc/21/360eee.md?p=13), or [device](/usc/21/321.md?p=h-1) pursuant to an application submitted under this subchapter, the [Secretary](/usc/21/321.md?p=d) shall accept data from clinical investigations conducted outside of the United States, including the European Union, if the applicant demonstrates that such data are adequate under applicable standards to support approval, licensure, or clearance of the [drug](/usc/21/321.md?p=g-1), biological [product](/usc/21/360eee.md?p=13), or [device](/usc/21/321.md?p=h-1) in the United States.
- (b) **Notice to sponsor—** If the [Secretary](/usc/21/321.md?p=d) finds under [subsection (a)](#a) that the data from clinical investigations conducted outside the United States, including in the European Union, are inadequate for the purpose of making a determination on approval, clearance, or licensure of a [drug](/usc/21/321.md?p=g-1), biological [product](/usc/21/360eee.md?p=13), or [device](/usc/21/321.md?p=h-1) pursuant to an application submitted under this subchapter, the [Secretary](/usc/21/321.md?p=d) shall provide written notice to the [sponsor](/usc/21/360fff.md?p=8) of the application of such finding and include the rationale for such finding.

## Source credit

(June 25, 1938, ch. 675, § 569B, as added Pub. L. 112–144, title XI, § 1123, July 9, 2012, 126 Stat. 1113; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(Q), Dec. 13, 2016, 130 Stat. 1155.)

## Notes

### Editorial Notes

### Amendments

2016—Pub. L. 114–255 substituted “drug, biological product, or device” for “drug or device” wherever appearing.