See below from the FDA website which seems to say the the submitter is entitled to ask for and receive monthly status updates. If that is true then all of this speculation is really not necessary. I don't see anything prohibiting the publication of these updates. so why aren't they? I'm certainly no expert but if one wanted to inform one's shareholders and the public, wouldn't publishing the monthly status report be the simplest way? Or is speculation what Dean wants?
510(k) Status Program
Submitters may request information on their 510(k) review status 90 days after the initial log-in date of the 510(k). Thereafter, the submitter may request status reports every 30 days following the initial status request. To obtain a 510(k) status report, the submitter should complete the status request form, FDA 3541, and fax it to the CDRH office identified on the form. Within three working days after a status request is received, CDRH will send the submitter a fax that includes:
* The ODE or OIVD division or branch to which the 510(k) is assigned;
* The last action, and date of action, that ODE or OIVD has taken regarding the 510(k);
* The position of the 510(k) in the reviewer's queue; and
* The average review time for the division or branch
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