Action on IDE Applications Approval or Disapproval §812.30 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.


So after they submit an IDE it will take 30 days for FDA to approve it if everything is in order, if i,m reading this correct?

Question is how long will it take SSH to submit the new IDE? Ill have to email the company what there timeline is.

Guessing 3-6 months?