Title 21, Food and DrugsRelease 119-110

§360bbb–8b Use of Clinical Investigation Data From Outside the United States

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER V — DRUGS AND DEVICES › Part E — General Provisions Relating to Drugs and Devices › § 360bbb–8b

Last updated Sep 22, 2026|Official source

Summary

A federal reviewer must accept data from clinical trials done outside the United States — even trials run in the European Union — if the applicant shows the data meet U.S. standards and are strong enough to support approval, a license, or clearance for a drug, biological product, or device. If the reviewer finds the outside-study data are not good enough, they must send the applicant a written notice saying so and explain the reasons.

Full Legal Text

Title 21, §360bbb–8b

Food and Drugs, Source: USLM XML via OLRC

(a)In general

In determining whether to approve, license, or clear a drug, biological product, or device pursuant to an application submitted under this subchapter, the Secretary 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, biological product, or device in the United States.

(b)Notice to sponsor

If the Secretary finds under subsection (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, biological product, or device pursuant to an application submitted under this subchapter, the Secretary shall provide written notice to the sponsor of the application of such finding and include the rationale for such finding.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Amendments

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

Reference

Citations & Metadata

Citation

21 U.S.C. § 360bbb–8b

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110