Hey pennytiger – good find – thanks.
By my count, today is day 186? Day 180 would have been last Tuesday the 19th?
Either way, I believe this is not going to happen either soon or imminently, but yesterday because my sense is that legal oversight staff and final approvals of content by management are currently underway, given that the FDA announced that all comments had been reviewed on June 20. Seems to me that the bulk of the work following June 20th in converting the proposed Order into final format would entail incorporating any worthwhile comment data and drafting Special Controls for labels, etc.
So, yesterday could also be recently. Regardless, I would suspect since this appears to be a major paradigm shift for the device world, FDA, big pharma and the American people in general, it warrants care and caution in getting it right. Bottom line, 'now', or 'this week' both work for me and would make a lot of folks happier knowing that pain management alternatives and choices for Americans are truly on their way through the regulatory processes to market, instead of just talk and waiting.
The final Order for the new classification of devices, initiated by the FDA on February 20 2014, will also go a long way in silencing the ever-ranting critics who allege that the FDA is under the spell of the chemical drug lobbyists and big pharma, NOT! Intelligent people know that is not the case, just read the April article by FDA Commissioner Hamburg and look at the plethora of anti-Rx drug and opiate articles in the last 6 months. Still, it will be refreshing to silence the cynics. Thanks again.
