An Early Feasibility Study (EFS) is performed early in the device development process to evaluate the device functionality and preliminary clinical safety when non-clinical testing is unable to provide this information. Insights obtained from an EFS may be crucial in the device development process as the device design is still provisional and subject to modifications. An EFS in the U.S. is required to follow the same regulations as pivotal studies (21CFR812); however, success depends on the proper mindset from the sponsor and investigators due to the unique objectives. The FDA guidance for Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies outlines the EFS regulatory pathway, and we have previously discussed the ways sponsors should approach an EFS in order to be successful.
There are significant differences in the logistics of an EFS versus a pivotal study, and knowing how to conduct one does not guarantee success with the other. Below are some of the differences between an EFS and pivotal study.
Unlike a pivotal study, an EFS has a broader purpose. Data obtained from an EFS facilitates the device development process, by helping to:
Contact our Clinical Research team for more information about designing EFS, navigating the EFS pathway with FDA, and conducting a study that allows feedback to flow amongst the stakeholders so your novel device may be clinically tested and data obtained in the most efficient way.
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