It's the same old story (see below) with the FDA having been spearheading the regulatory changes for at least 3 years to permit OTC sales of ActiPatch in the USA, which will eviscerate the Big Pharma's drug cartel position for many years as the only solution to chronic and acute pain for >140Million Americans.
FDA has gone through the growing pains of ramping up its CDRH Branch; hiring on staff to assess the PEMF science; renamed it SWT - Short Wave Therapy; reclassified it from Class III to Class II; accepted BIEL's Knee and Plantar Fasciitis Trials; published its intent to accept RWD - Real World Data in its decision making; published in the last week its intent to accept PPI - Patient Performance Information in its decision making; and has adopted the position of assessing the UK Registry of patient feedback data on back pain relating to BIEL's ActiPatch. No question that claims of 510(k) denial by the FDA are totally false, embarrassingly false to those making such claims.
So, the same old story reference above refers to where do people want to be - back in the dark ages, head in the sand, petulant, cynical? Or, at least a little curious about BIEL's disruptive technology approaching American shores like a tsunami. You're absolutely correct yankee - FDA is moving with urgency, has been for a long time, to combat the drug analgesic epidemic here and they do want to be on the right side of the issues. It's all about choice and with tens of thousands of man-hours and millions invested in this dramatic change in the pain management culture, FDA clearly made its choice a while back. ActiPatch OTC USA Soon
