An Investigational Device Exemption (IDE) is a regulatory mechanism that allows an investigational medical device to be used in a clinical study to collect safety and effectiveness data.
In clinical research, an IDE may be required before a significant risk device can be studied in human participants in the United States. IDE requirements help ensure appropriate oversight of investigational device studies, including protections for research participants and compliance with applicable FDA regulations. Depending on the device and study, an IDE may require FDA approval before research begins. IDE studies are also generally subject to institutional review board (IRB) review and informed consent requirements.