Can foreign/international data be used as the sole support of a marketing application?
Yes. The PMA regulation, 21 CFR Part 814, allows foreign data to be used as the sole support of a marketing application but only if (1) the data are applicable to the U.S. population and to U.S. medical practices, including laboratory practices, (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 FDA inspection or, if necessary, FDA can validate the data on site (21 CFR 814.15(d)). For IVD devices, this may include consideration of differences in population demographics, disease prevalence, disease presentation, laboratory practices, and medical standards of care. If the sponsor plans to submit an application based solely on foreign data, FDA recommends that the sponsor consult with the reviewing division prior to submission of the application.
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- Can foreign/international data be used as the sole support of a marketing application?
