I’m going to keep reading between the lines…
I’m definitely linking any recent statements or inferences regarding the FDA’s approval to distribute under IDE. The FDA appears to have no problem with radiation levels or else there would probably be no Investigational Device Exemption (IDE). It’s my understanding that the IDE was expected. This leads me to believe Dean & Company have been working behind the scenes with this in mind.
The FDA’s Center for Devices and Radiological Health (CDRH) spent 9 months evaluating the Dominion before classifying it an IDE and handing it off to the Office of Device Evaluation (ODE). It looks to me that the ODE is the investigative liaison between the CDRH and the device sponsor. Under the IDE, the additional information and documentation that is needed can be freely discussed and exchanged, respectively. This IDE procedure appears to shorten the approval time. In an open dialogue format with the ODE, Dean will know exactly what information is needed by the FDA; probably certain images and radiation data in various real life settings.
There is no substantial equivalent to a predicate device regarding the Dominion. There are many other diagnostic devices that come close, but not entirely. I sense that the FDA needs to establish precise documentation in a real life setting with respect to the main feature of the Dominion, which is the Real-Time 3D Imaging.
My original apprehension regarding IDE revolved around my perceptions of a process that probably resembles the FDA’s Investigational New Drug (IND). I am now viewing the IDE with a shorter time span regarding additional images and radiological data versus the extensive studies related to IND.
Any comments or corrections are welcomed.
In the meantime, I’m going to keep reading between the lines…
"Opportunities are best viewed through the eyes of a tiger"
