814.15 Research conducted outside the United States.§ 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]