What do you think the FDA are doing every time Vivos walk into a pre-sub meeting with the Mayo clinic reps at their side. Yes that's right. REVIEW.
Don't believe me, believe the FDA's own written comments
The EFS Program provides a mechanism for innovators to work directly with sponsors, FDA review teams, and clinicians to collaborate early so they can increase the efficiency of their device development. Early clinical experience obtained from an EFS can provide insights for sponsors and FDA review teams into issues such as device proof of concept, patient characteristics that may impact performance, operator technique refinements, device safety, necessary device modifications, and human factors.
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