The FDA's goal is to complete review (i.e., reach a final decision on Substantial Equivalence) within 90 total cumulative review days, which clock begins upon official receipt by the FDA of each submission by the applicant (which Dean has publicized each time) and goes on hold each time the FDA sends back a formal letter information request (and then restarts again when the FDA receives a re-submission). The FDA aims to issue a final decision (i.e., SE) on a first submission within 90 days. If the FDA has to come back to the applicant with a formal written request for additional information, they than aim to complete the review of the first re-submission (i.e., reach a final decision on S.E.) within 75 days from the receipt of the re-submitted application or 90 cumulative days (FDA's review time with the first application and the re-submitted application combined), whichever time is greater (i.e., you should always expect at least 90 total days). If the FDA again needs to make another formal additional information action request, you move to the third box, in which the FDA has set a goal of completing its review (i.e. reaching a final determination on S.E.) within 60 days of receipt of the 2nd or later re-submission or 90 cumulative days, whichever is longer.
Applying this to the DViS 510(k) application process, we are now in the third submission (i.e., a second or later AI action). That triggers the FDA's 60-day goal (which they claim to meet 90% of the time) unless the FDA has not already used 90 cumulative days. The FDA has already consumed more than 90 cumulative review days on the first and second DViS submissions, so the 60-day mark is the applicable one. According to Dean, however, on each of his 4 previous successful 510(k) applications, the final go round with the FDA has always been 30-days, not 60. In his experience, each time he has been through this process, the FDA has consumed its 90 cumulative days on the first couple of passes, and on the final pass, there is generally silence for 30 days and then approval.
So best case, that 30 day period has passed and we are in the "any day now" zone. Worst case, they are applying the 60-day goal, which they meet 90% of the time, which puts us at June 8 (FDA confirmed receipt of the re-submission on April 9). From Thursday May 20 (tomorrow) to Tuesday June 8, there are only 8 trading days.
I am standing by Dean's experience that the final pass is 30-days, but even if you go with the web link posted by BennyJ, the worst case is 60 days from receipt of the re-submission in early April. All of that should also be viewed in the context of the other statements in that link, particularly the characterization of the informal information requests that Dean told us he received in mid-April; i.e., "FDA generally requests AI by means other than a letter when the agency believes the additional information is relatively minor in nature (e.g., a simple change to the device's proposed labeling) and can be provided quickly," and "an informal AI request does not result in the 510(k) being placed on 'hold.'" That tells us that the only issues identified by the reviewers down the stretch here have been minor in nature. Since there were only minor issues identified, I'm very confident that approval will be the result, and when we have it is as early is today and as late is early June.
I have maintained that we should have had it already, and I stand by that. I think the FDA is late, but based on BennyJ's link, I suppose another 8 trading days could be in the cards. If it was always going to be early June, then I apologize to everyone for a flawed analysis, but I still believe that 30-days was the right mark for the analysis.
