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Code of Federal Regulations Title 21. Food and Drugs § 21.814.15 Research conducted outside the United States

Current as of January 02, 2025 | Updated by Findlaw Staff

(a)Data to support PMA. If data from clinical investigations conducted outside the United States are submitted to support a PMA, the applicant shall comply with the provisions in § 812.28 of this chapter, as applicable.

(b) As sole basis for marketing approval. A PMA based solely on foreign clinical data and otherwise meeting the criteria for approval under this part may be approved if:

(1) The foreign data are applicable to the U.S. population and U.S. medical practice;

(2) The studies have been performed by clinical investigators of recognized competence;  and

(3) The data may be considered valid without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA can validate the data through an on-site inspection or other appropriate means.

(c) Consultation between FDA and applicants. Applicants are encouraged to meet with FDA officials in a “presubmission” meeting when approval based solely on foreign data will be sought.

(d), (e) [Reserved by 83 FR 7387]

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.814.15 Research conducted outside the United States - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-814-15/

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