I know it's hard to stomach how slow and often incompetent our federal government is, but that is the reality. But to be fair to the FDA, these types of tech issues happen all the time even outside the context of the government. There is an entire cottage industry that has made billions of dollars helping to process and produce large packages of electronic files in the regulatory world. If it was as simple as sending an email or posting on a message board, there wouldn't be billions of dollars spent on these document production vendors. That's the reality. In mega productions, you have little nit problems like this all the time.
I would agree with you if the FDA reported back to Dean 90 days after April 5 to say they couldn't open his application. What the heck were they doing all that time! But that's not what happened. They reported back that they were having trouble opening a couple of files. That's probably a couple out of hundreds. For all we know they were marketing photographs of the device or images from the predicate devices. The FDA had a massive application to get through, and they were going through it one page at a time. They had a problem opening a couple of files and asked for them again and got them. I am certain that is a daily occurrence in their offices and not anything that made them bat an eye. Not sure what else to tell you, but we deal with this all the time in my practice. It's just a part of practicing in an electronic world.
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