Chilean device-trial data can support US FDA submissions under the foreign-data framework of 21 CFR 812.28 — when the study is run to Good Clinical Practice with documented ethics review and adequate device oversight. That is eligibility, not a guarantee: FDA judges the data, not the country. Chile's framework is built to produce data FDA can judge.
FDA's regulation on foreign clinical studies not conducted under an IDE — 21 CFR 812.28 — sets the conditions under which data from outside the United States can support a device submission: the study must be conducted in accordance with Good Clinical Practice, with documented independent ethics review, and FDA must be able to validate the data. The rule evaluates the study's conduct, not its geography.