Assertion: trial's purpose | /r/HasProperty | primary
Facets:
Source sentences:
text: In addition, for the clinical trial to be an "applicable device clinical trial," the trial must meet the definition at 42 CFR 11.10(a), its primary purpose must be other than a feasibility study, and it must meet one of the following conditions: (1) at least one study facility is located in the U.S. (or a U.S. territory); (2) the study is conducted under a U.S. Investigational Device Exemption (IDE); or (3) the device product is manufactured in and exported from the U.S. (or a U.S. territory).