Today the FDA updated our CDRH Learn Module on Early Feasibility Studies for Medical Devices to include a new section on the Device Evaluation Strategy. A Device Evaluation Strategy within the Report of Prior Investigations describes and justifies the appropriate testing to support initiation of a clinical study. The updated section of the module will provide information on how to develop your Device Evaluation Strategy for submission to the FDA.
Also found within the module is an overview of the CDRH Early Feasibility Study Program and a description of the processes for working with FDA on early feasibility study projects.
Food and Drug Administration Center for Devices and Radiological Health