# 21 CFR § 814.15: Research conducted outside the United States

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-814.15

## Section

- **Citation:** 21 CFR § 814.15
- **Heading:** Research conducted outside the United States
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES > PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES > Subpart A—General

## Text

(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]

## Nearby sections

- [21 CFR § 814.1 § 814.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.1.md)
- [21 CFR § 814.2 § 814.2 Purpose.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.2.md)
- [21 CFR § 814.3 § 814.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.3.md)
- [21 CFR § 814.9 § 814.9 Confidentiality of data and information in a premarket approval application (PMA) file.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.9.md)
- [21 CFR § 814.15 § 814.15 Research conducted outside the United States.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.15.md)
- [21 CFR § 814.17 § 814.17 Service of orders.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.17.md)
- [21 CFR § 814.19 § 814.19 Product development protocol (PDP).](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.19.md)
- [21 CFR § 814.20 § 814.20 Application.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.20.md)
- [21 CFR § 814.37 § 814.37 PMA amendments and resubmitted PMAs.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.37.md)
- [21 CFR § 814.39 § 814.39 PMA supplements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.39.md)
- [21 CFR § 814.40 § 814.40 Time frames for reviewing a PMA.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.40.md)
- [21 CFR § 814.42 § 814.42 Filing a PMA.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.42.md)
- [21 CFR § 814.44 § 814.44 Procedures for review of a PMA.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.44.md)
- [21 CFR § 814.45 § 814.45 Denial of approval of a PMA.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.45.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-814.15. Check the current official text before relying on it. Not legal advice.