Bioelectronics Corp (BIEL)

[Dubb10]

You're giving way too much credit to Actipatch in FDA deciding to change the classifcation for all SWT devices. If it was due to Actipatch, then FDA would've reclassified the devices a long, long time ago.

FDA decided to reclassify non-thermal shortwave devices because:
a) They were not life-sustaining, hence they are not Class III devices.
b) The heat-related safety issues listed in the original proposed rule did not apply.
c) The special controls listed in the Final Rule could provide reasonable means of satisfying any concerns. The advisory panel of doctors and scientists for the reclassification meeting several years ago felt comfortable about this which gave FDA the green light to proceed.