History of the Early Feasibility (EFS) Program

Clip 1

EFS was established by the FDA as a way to shorten the timeline to approval for devices in the U.S.


The Regulatory Environment Prior to EFS

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Prior to the EFS program devices took longer to receive approval. shifting clinical program to Europe.


EFS' Impact on the Funding Environment (Part 1)

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Prior to the EFS program, the overall timelines to market for Class III devices did not sync with investor timelines.


EFS' Impact on the Funding Environment (Part 2)

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Without the EFS program, many Class III device companies would have ceased to exist.


Risk Mitigation Strategy Applied to Establish EFS

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The elimination of non-value added activities and the introduction of risk mitigation guides EFS.


Early Feasibility Studies Allow for Flexibility in Design Changes

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A company can make changes to the device design mid-stream in an Early Feasibility Study (EFS).


EFS Studies Can Dovetail Into Pivotal Trials

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A successful EFS can be extended and transition right into a pivotal trial.