Vivos Inc (RDGL)

[kayak_wench]

Recall that the IDE Vivos submitted is for an Early Feasibility Medical Device Clinical Study (EFS). Submitting an an EFS was the FDAs recommendation to the company. The EFS Program is open to devices subject to Premarket Approval (PMA), Premarket Notification (510[k]), De Novo classification, or Humanitarian Device Exemption (HDE). The IDE, if approved will initiate the EFS.

I asked ChatGPT 4o (the one that has access to the latest web) what percentage of Investigational Device Exemptions (IDEs) submitted as part of devices being developed under FDAs Early Feasibility Medical Device Clinical studies are typically approved by the FDA?

It responded with the following pretty much validating what most here have been saying...IDE submission if very likely after working closely with the FDA for over four years.

The approval rate for Investigational Device Exemptions (IDEs) submitted for Early Feasibility Medical Device Clinical Studies by the FDA is generally high. The FDA has implemented measures to facilitate and streamline the approval process for these studies, recognizing their importance in early device development. The Early Feasibility Study (EFS) Program includes mechanisms for interactive review and assistance in submission preparation, which helps sponsors meet the necessary requirements for IDE approval. Key elements of the approval process include the acceptance of less nonclinical data compared to traditional feasibility or pivotal studies, and the ability to modify devices and clinical protocols during the study while maintaining compliance with human subject protection requirements. This approach is designed to encourage innovation and expedite the development of new medical devices by allowing early clinical evaluations that provide essential insights into device safety and functionality.