This session will provide the participant with several real-world examples of the benefits and risks of conducting early-phased medical device clinical trials, and the strategies involved in optimizing this avenue fo regulatory submissions. The participant will obtain tools to develop successful clinical and regulatory strategies for new devices and indications.
Define FDA's Early Feasibility Study (EFS) Program.
Outline the risks/benefits of participating in the EFS program for early-phased clinical trials.
Outline strategies to leverage EFS protocols for PMA and 510 submissions.
VP, Clinical and Regulatory Affairs,
Conformal Medical, Inc.