Any clinical study performed in the United States that involves human subjects is required to have U.S. institutional review board (IRB) approval prior to initiating the clinical study. This involves approval of the clinical study protocol, informed consent form and related materials, and all study principal investigators. Furthermore, a clinical study performed in the United States using an investigational device that has not been approved or cleared by the FDA for the intended application must also have an investigational device exemption (IDE) approved by the governing IRB prior to initiating the study. If the clinical study involves a significant risk device, the IDE must also be approved by FDA prior to the study’s initiation. Regulatory Insight has extensive experience attaining IRB approval for numerous and varied studies and their principal investigators. We can work with your local IRB, such as one affiliated with a particular university where the research will take place, or if you are not affiliated with a local IRB, we can recommend and work with either a suitable local or national IRB. Regulatory Insight can help you to determine whether your study is a significant risk or non-significant risk study. In the case of a non-significant risk study, we can formulate the strategy to submit the non-significant risk application for your study to the IRB. In the case of a significant risk device, we can attain both IRB and FDA IDE approval for the clinical study protocol and principal investigators simultaneously to save your company cost and time.