N
normhowe
Hello,
We are trying to define the differences between pre-clinical and clinical research. We have a simple class 2 device. Let's just say for the purpose of discussion that it is worn on the wrist. If, during the design of a modification of the device, we were to try the device on our own wrist, just to see if it fits. Would that be considered a clinical trial? thus requiring an IDE and approval from an IRB?
We are trying to define the differences between pre-clinical and clinical research. We have a simple class 2 device. Let's just say for the purpose of discussion that it is worn on the wrist. If, during the design of a modification of the device, we were to try the device on our own wrist, just to see if it fits. Would that be considered a clinical trial? thus requiring an IDE and approval from an IRB?