IDE (Investigational Device Exemption)

An Investigational Device Exemption (IDE) is a regulatory approval that allows a medical device to be used in a clinical study to evaluate its safety and effectiveness before it is commercially available. It permits researchers to test new or modified devices on patients under specific conditions, ensuring rigorous oversight by authorities like the FDA. The IDE ensures that patient safety is prioritized while gathering essential data to support possible future approval and widespread use of the device.