Replies to post #177270 on Vivos Inc (RDGL)

[doccjc]

Once a tenor , always a tenor. FUD

[rickstereo3333]

Based on the text for the IDE process he could actually be right since the 30 day period commences from the date the FDA acknowledges receipt of the submission as opposed to when Vivos submitted it.

Did Vivos indicate what date the FDA verified receipt of the submission?

This however does not preclude the fact that the FDA/IRB could give the go ahead prior to the 30 day "no response" approval.



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.