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§ 814.15 - Research conducted outside the United States.

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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.

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:

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

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

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.

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.

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§ 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.
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§ 814.17 - Service of orders.