The sponsor-investigator makes the initial risk determination for the proposed study and presents it to the IRB. Refer to FDA “Guidance for Institutional Review Boards and Clinical Investigators, Significant Risk and Nonsignificant Risk Medical Device Studies, 2006” for examples of non-significant and significant risk devices. The IRB then reviews the sponsor-investigator’s risk determination and agrees or disagrees. The FDA is available to help the sponsor-investigator and the IRB in making the determination. If needed, the FDA is the final arbiter.
Refer to the FDA website for more information on the IDE process.