21 U.S. Code § 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 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 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 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.