Design and execution of clinical studies for medical devices

Summary form only give. You have a great new medical device that had good results in your animal studies and now you want to test it in a clinical study on human subjects. What are the key steps in designing and executing human subject studies so you can use the data to support your regulatory submissions? Some aspects that will be covered in this discussion group are the steps generally required to set up and manage a study of a medical device that complies with the Good Clinical Practices (GCP). This discussion will focus primarily on the requirements for clinical studies that will be used to support evidence of safety and effectiveness to the FDA.