21 CFR § 814.15 - Research conducted outside the United States.

---
identifier: "/us/cfr/t21/s814.15"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 814.15 - Research conducted outside the United States."
title_number: 21
title_name: "Food and Drugs"
section_number: "814.15"
section_name: "Research conducted outside the United States."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "814"
part_name: "PREMARKET APPROVAL OF MEDICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 372, 373, 374, 375, 379, 379e, 379k-1, 381."
regulatory_source: "51 FR 26364, July 22, 1986, unless otherwise noted."
cfr_part: "814"
---


# 814.15 Research conducted outside the United States.

(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.

[51 FR 26364, July 22, 1986; 51 FR 40415, Nov. 7, 1986, as amended at 51 FR 43344, Dec. 2, 1986; 83 FR 7387, Feb. 21, 2018]