I hope people know that "deadline" does not mean diddlysquat...
Want an example?
I watched this company wait 15 months for an answer from the FDA...that's 15 months after answering the FDA inquiries...the application was submitted before that.
"In the first quarter of 2007, we received approval from the FDA for our Investigational Device Exemption (“IDE”) application for the clinical evaluation of our OLpur H2H module and OLpur MD 220 Hemodiafilter. We completed the patient treatment phase of our clinical trial during the second quarter of 2008. We submitted our data to the FDA with our 510(k) application on these products in November 2008. Following its review of the application, the FDA requested additional information from us. We replied to the FDA inquiries on March 13, 2009.
On June 30, 2010, we received a final decision letter from the FDA for our 510(k) submission which stated that the FDA could not reach a substantial equivalence determination for our hemodiafiltration (HDF) system"
After being in a few companies waiting for FDA device approval,
it is my experience that they typical follow the same pattern.
The company submits the 510(k)...
at the end of the period the FDA will request more information,
which resets the "clock"...
Many times its denied the first time around.
The company has to re-submit the 510(k)...
the FDA asks more questions...
The process often takes years.
From November 2008 to April 2012 for the example above...
a simple blood filter for dialysis.
It was approved in the EU/Canada LONG before the FDA decided to "approve" it...
This is hardly an isolated case...
I've watched many small companies deal with this.
OF COURSE...ADMD could get approved today/tomorrow/next week...
I just sayin' the FDA does not give a crap about their alleged timetable.
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