FDA has updated the CDRH Learn Module on Early Feasibility Studies for Medical Devices to include a new section on the Device Evaluation Strategy. The updated section of the module provides information on developing a Device Evaluation Strategy.
The updated module is available through CDRH Learn at http://www.fda.gov/Training/CDRHLearn/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
Open the dropdown “How to Study and Market Your Device” and look for “Clinical Studies/Investigational Device Exemption (IDE)”