Vivos Inc (RDGL)

[rickstereo3333]

IMO the text indicates that APPROVAL of IDE can occur at any point but the actual Clinical INVESTIGATION can only begin 30 days after the FDA notified the Sponsor it has received their IDE application.

Even if the 30 days has elapsed the Sponsor can begin its clinical investigation only if it had also received prior IRB approval.

FDA --> Approval of IDE for Investigation
FDA + IRB --> Proceed with Investigation after 30 days has elapsed




From the link in post# 176688 by mc73

FDA Action on IDE Applications
Approval or Disapproval §812.30
FDA will notify the sponsor via email of the date it receives an IDE application. FDA may approve, approve with modification, or disapprove an IDE application. FDA may request additional information about an investigation. The sponsor may provide the requested information or the sponsor may treat such a request as a disapproval of the application and request a hearing in accordance with 21 CFR 16. The clinical investigation may begin after FDA and the IRB approves an IDE for the investigation. An investigation may begin 30 days after FDA receives the IDE application for the investigation of a device if IRB approval has been obtained unless FDA notifies the sponsor that the investigation may not begin.