Yes, but only if warranted. 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
through an on-site inspection or other appropriate means (21 CFR 814.15(d)).
For IVD devices, FDA would consider 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.
