IDE Approval Process

Investigations covered under the IDE regulation are subject to differing levels of regulatory control depending on the level of risk. The IDE regulation distinguishes between significant and nonsignificant risk device studies and the procedures for obtaining approval to begin the study differ accordingly. Also, some types of studies are exempt from the IDE regulations.

Who Must Apply for an IDE

The sponsor of the clinical trial is responsible 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 U.S. must have a U.S. sponsor. Under certain circumstances, the clinical investigator may wish to submit an IDE and would, therefore, also act as the sponsor of the study.

When to Apply

Study approval must be obtained PRIOR to enrolling patients at the study site. Each site must have approval from the reviewing IRB for that site prior to beginning the study. For significant risk device studies, in addition to IRB approvals, the sponsor must also have an approved IDE from FDA prior to beginning the study at any site. The review of applications to FDA and to the IRBs are independent and, therefore, may be submitted simultaneously.