I would think it would probably be a flat fee for the process, if not, they should only pay for the law firms time for the submittal process rather than a continuous 9 months. After all, they won't need to work on this daily for 9 months.
The FDA would love to see units out in the field. Imagine what it would do for the waning investors confidence. How could Dean Janes possibly think that a radiation emitting rotational device could ever possibly avoid this critical step? Instead of doing what the FDA wants, Dean Janes goes out and hires the Big Guns to try and find a loophole in an invincible FDA position. More time and more money will be spent. Why doesn't he provide them with what they want?????????????????????
That will be negotiated by Consul, it may call for PMA or more likely the DVIS could be allowed to market as Class II device with("Special Risk Based controls"). This is the ball game going forward. It can be a Home Run or a Triple minimum, because the whole point of this Process is to inject a metric of safety in the use of a device they were unable to classify.
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