Who Must Apply for an IDE

The sponsor of the clinical trial is responsible103 for submitting the IDE application to FDA and obtaining Institutional Review Board (IRB) approval before the study can begin. Foreign companies wanting to conduct a clinical study in the United States MUST have a US sponsor.104 Under certain circumstances, the clinical investigator may wish to submit an IDE and would, therefore, also act as the sponsor of the study.

Updated: October 3, 2015 — 2:08 am