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 for regulatory submissions. The participant will obtain tools to develop successful clinical and regulatory strategies for new devices and indications.
Upon completion of this Webinar, attendees should be able to:
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
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