21CFR814.15

§ 814.15 Research conducted outside the United States.

Regulation 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: (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. (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.

Authority

21 U.S.C. 351,352,353,360,360c-360j,360bbb-8b,371,372,373,374,375,379,379e,379k-1,381.

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Related Guidelines (10)

21CFR814.15 — § 814.15 Research conducted outside the United States. | CFR Explorer | BioRegHub