The two general things I got from last year's meeting was that FDA believed proper labeling can curb any safety issues, plus they had concerns about standardization of the clinical tests (scales, sample size, locations, etc). It appears that the major issues they had mentioned in the warning letter (other than the unapproved OTC distribution of course) revolved around labeling. Some clinical tests used an approved scale (such as Biel) for pain, one didn't. If memory serves me correct, they were in favor of using the number of pills taken daily throughout the trials as an acceptable form of reference/measuring. How to measure edema was an issue. Ensuring control of a patients use of active and sham devices in addition to documentation appeared to be major for the FDA consultant as far as Biel's tests. It was interesting to see the efficacy issues for Biel's blepharoplasty clinical tests.
Yes, PEMF has been around for awhile and we are just dealing with a shrinking of the circuits and power sources. I think the disconnect with the FDA reviews was based more around the inability to understand the safety issues were centered around power. I thought about using the Freedom of Information database to request additional info from the FDA to hopefully see what the early dialogue was between manufacturers and FDA, but since I believe SWT will be OTC with labeling controls, I don't see the point now. Plus, I'm not sure how much they would actually disclose. I think there was a petition about reclassification, prior to the one we saw over the last couple of years.
The main issues w/ our ISO audits always revolve around documentation control. Nothing that an organized system can't resolve.
Market Data 
Markets 
AI
