I hope that you are correct wyatt. Unfortunately the FDA does not operate under the rules of a normal business. They only have to answer to Congress and the President. If you or I miss a deadline at work we would have some explaining to do, to the client and our boss. But the FDA is the "Only Game In Town" when it comes to government approval for a medical device. As Ms. Burns in the Medical Device Division wrote when she replied to my inquiry regarding the FDA not meeting its own 180 day goal in early September,there is an "ongoing balancing of priorities". I read that as we have more pressing issues to deal with.
I believe it was simpsonly who speculated that 180 days to the FDA may exclude weekends and holidays. This would place us into late October for the goal. However Ms. Burns, who could have used this as an easy excuse, mentioned nothing to contradict my statement that her department had missed its 180 day goal.
The only leverage that we have over the FDA is through our Congressman and Senators. Write them and let them know that 46 Americans die each day from pain medication abuse. PEMF offers a safe non addictive alternative to opiate drugs for relief from pain. The USA is decades behind the rest of the world in utilizing this technology because of poor leadership (allegiance to big pharma) in the FDA.
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