Hey art - as I've said before, various good guys here were advised by senior FDA staff members in multiple e-mails that they are fully aware of all the ramifications and the legitimate urgency associated with the Final Rule to their own Proposed Rule, which is now being revised and I guess going through their internal proofreading and approval processes.
Many of us suspect they also may well have taken another look and re-think on the science and safety aspects based on the public comments made last Spring to determine and assure themselves that indeed there are zero negative side-effects and only minor Special Rules and Label Instructions required. For the FDA to state to our citizens, and the world, that PEMF/SWT devices are safe, with the above exceptions, providing the electronics, assembly and material composition are safe, is an important due diligence step and they need to be confident they are correct. Just sensible, don't you think?
Good Guys were also advised by e-mail that this Proposed Rule is only one part of a huge workload of projects on the table at the CDRH and will be dealt with "in a timely fashion". I respect this process because every individual waiting for something from the FDA believes their issue, or project, is of the highest priority, whether it be ear wax, blog basher medicine or BIEL type products. Tough to judge and affix priorities when every damn thing one is working on is top priority and urgent to someone else and there is little, if any, praise from the disgruntled public or industry when the correct decisions and rulings are made. I get as impatient as anyone from time to time art, all I can say is more patience. When I get really picced, I let loose here on iHub and then, instantly, I feel much better! A little of "The Best Yam Vodka On Earth" from Jim Eason, Master Distiller over at Covington Spirits helps too. Patience art, the train is in motion.
