I'm wondering if the FDA is even working on the IMGG 510K. It's been a long time since anything has happened. Way too long. It's starting to smell like the application is on ignore.
The article noted that "the FDA now reviews more than 90 percent of 510(k)s within 90 days, compared to 75 percent prior to 2003, Shuren said. “This means nearly 500 more 510(k)s receive a timely review each year than at the pre-user fee performance level.”
My concern is 1- Does Dean know something (denial/delays/additional info required) that he is electing not to share with investors? or 2- FDA has decided that this device is not worthy of a review? or 3- They really are backed up at this point that we are actually falling into the lowest 10% that exceeds 90 days and beyond
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