Paradigm Medical Industries Inc. (PDMI)

[stervc]

The Next FDA Approval Committee for PDMI/PDMID…

The next FDA approval committee to take place for the device that PDMI/PDMID is submitting their 510(k) application for FDA approval is scheduled to take place on Feb 18, 2011 as if have highlighted from the FDA link below:

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm153468.htm


PDMI/PDMID has already submitted their 510(k) application for FDA approval. If for some reason it is not approved and needs to be resubmitted, I am confident that it will be re-submitted on the upcoming committee on Feb 18, 2011. A long while back, I spoke to some of the FDA officials over the phone. Here’s what I was told in general as I will reference it to PDMI which could be verified from the link below under the section towards the end titled 510(k) Status Program:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm

FDA approval for a device usually takes less than 90 days providing everything is properly done. Since PDMI has already submitted this 510(k) application before and have been going back and forth with the FDA officials over the past 20 months or so to ensure that everything is in order, I expect that we could possibly see an approval any day now. If not, then I am confident that they will re-submit their 510(k) application for the upcoming committee on Feb 18, 2011.

Under the 510(k) Status Program, PDMI is only required to request for an update of the status of their 510(k) application 90 days after their initial log-in. Their initial log-in was months ago as many of who have been following PDMI already know. PDMI can only request status reports every 30 days following the initial status request. PDMI will obtain a status report by filling out the status request form, FDA 354114, and fax it to the CDRH office identified on the form. Then within three working days after a status request is received, CDRH will send PDMI a fax that includes the last action taken on their submission and all other pertinent information.

In my opinion, the FDA officials having questions with the PDMI/PDMID submission of their 510(k) application for FDA approval of their Retimax/Paramax device is a good thing in my opinion. There is not a denial process. You are either approved or they inform you what is required for you to do in order to obtain approval. They will inform you as often as necessary until you are approved. The only way they would not coordinate with you is if they believed you had no chance of approval. This means that the longer that PDMI continues to submit and re-submit their 510(k) application for approval, the greater the chances that it will be approval the next time around in the queue.

These thoughts can be confirmed from speaking to the FDA officials. I recommend all do their research to confirm their own thoughts, but I am still confident that somehow PDMI/PDMID will figure this out. I would hate to be wrong about this, but this is how I am seeing things from my coordination with some neutral FDA officials on the matter.

v/r
Sterling