Cafa Where did you get the 45 days from? It is 30 days according...

Cafa
Where did you get the 45 days from? It is 30 days according to this link.
http://www.fda.gov/MedicalDevices/D...alDeviceExemptionIDE/ucm046164.htm#fda_action

Extract:
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.

The clock starts from the date of FDA receipt, not lodgement. Also in my experience, when FDA say 'days' it means calendar days. Whichever way you look at it, the 30 days are well and truly up.