IDEA (Investigational Device Exemption)

An Investigational Device Exemption (IDEA) is a regulatory approval that allows medical device developers to test their new devices in clinical trials. This exemption is granted by the FDA (Food and Drug Administration) in the United States. It enables researchers to gather safety and effectiveness data before seeking full approval for commercial use. Essentially, an IDEA allows patients to access new treatments while ensuring that the devices are rigorously evaluated to protect their health and safety during the testing phase.