The Anatomy of a Clinical Trial
The Stages of a Medical Device Clinical Trial
1. Start-Up
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2. Early Feasibility Study (EFS)
Early Feasibility Study (EFS) is used to study the safety and use of the device. At this point it is not used on patients, engineering and changes to the product can still be made. Focus is on safety, achieving the intended use, defining therapeutic parameters, and identifying failures or issues.
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4. Feasibility
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4. Pivotal
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5. Did the trial pass? Yes or No.
The next two stages for a medical device clinical trial depend on the success of the trial. If trials are successful they can end in a PMA (Pre-market Approval) or post-market study. If a trial does not meet the FDA’s standards it will undergoe a futility study to analyze what went wrong.