GG&G

[art2426]

>>>Moreover, the 2013 Panel concluded that the information presented to the panel was sufficient to establish special controls that are necessary to provide reasonable assurance of safety and effectiveness of SWT. Thus, the consensus of the 2013 Panel was to recommend that SWT be reclassified into class II (special controls).<<<



Thanks Threepointer for posting this. I have always thought that the delay in FDA OK, after creating the "new category" for PEMF, was due to establishing the "special controls". Information must be gathered, digested and confirmed as to label warnings and disclaimers: Length of time wearing device; restrictions on where to place device; WARNINGS to not use device do to prior health problems, etc etc. All this research takes time but we are going on 3 years since this panel decision. I know government works slow but GEEEZ!