Thanks for not bashing FDA as so many do on this forum. I've found the questions they've raised and suggestions made to be very reasonable and easily anticipated. The reviewers are suggesting what should be in an IDE application that's likely to get approved. Gotta put yourself in the reviewer's place. No sane FDA reviewer is going to sign off on human trials without sufficient controlled data to feel comfortable that the benefits of device trial outweigh the risks. Wish RDGL had been more proactive with FDA from get-go on testing needed, but that lost time can't be regained. They seem to be on right path now albeit at glacial place.
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