Title 21, Food and DrugsRelease 119-73not60
§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
Summary
The Secretary must accept clinical trial data done outside the United States, including the European Union, when the applicant shows the data meet U.S. standards and can support approval, licensure, or clearance of a drug, biological product, or device. If the Secretary finds the foreign data inadequate, the Secretary must send the application sponsor a written notice that explains why.
Full Legal Text
Title 21, §360bbb–8b
Food and Drugs, Source: USLM XML via OLRC
(a)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)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
Apr 5, 2026
Release point: 119-73not60