<< ATTENTION<<!!! From one of the trusted posters on yahoo UPDATE !!!!!! This is where we are at the moment with the FDA
Hi Everyone, This post is based on public information but I had contact with a certain person at the Agency to guide me through the process, it's not easy to find.
There is no specific time for a final order to be issued.
At this moment comments are being considered, responses to the comments and the final order itself are reliant on types of comments received and ongoing priorities.
The FDA is aware that there is significant interest from manufacturers, patients and stakeholders in bringing this classification effort into a timely conclusion.
Another item is that the FDA also proposes that 510k's be submitted withing 60 days of the effective date of the final order with special controls.
The FDA is also requesting comments if 60 days is enough time. This action with comments will also prolong the effective date. I can't figure out why there is only a 60 window to submit on a new classification, still trying to find out.
So while we are waiting for the partners, investors and hopefully Shoppers Drug Mart in Canada, follow the 515 Project Status page for updates.
Please note that the FDA did not mention "New clinical trials" must be submitted only special controls. Certainly there would not be enough time anyways. That's a great thing.
One more thing, if anybody has submitted a comment they would recieve a tracking number for confirmation as well to be used to search for an response to the comment.
Trust this helps. Less!!!
