Without meaning offence Legume, it's pretty straight forward. To get an IDE approved submit sufficient data (pre-clinical including animal etc.) to demonstrate the device is reasonably safe and has the potential to be effective. And provide a scientifically sound protocol. If you can't do both of these don't submit.
Given the current state of play it's clear the "expert" gap analysis, or the company's chosen interpretation of it, was seriously flawed. Someone did/does not understand the level of information required to demonstrate safety to the FDA.
I haven't been able to find anything about a 1st pre-IDE meeting by the way. The most CRITICAL first step in the regulatory pathway, especially for a significant risk device. 1700 pages additional submitted to respond to FDA feedback would indicate this step was skipped. A very unwise and costly mistake.
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