FDA attempting to reclassify CES devices – unwarranted

In August of 2011, we asked that practitioners and patients who use Alpha-Stim for CES purposes (i.e., anxiety, insomnia and/or depression) provide the Food and Drug Administration (FDA) with a letter stating how you use Alpha-Stim, how beneficial you find the device to be and if you believe it is safe. We were blown away by the support we received at that time. Since then we have been waiting for the FDA commissioner to rule on the comments FDA received from practitioners, the public and manufacturers of CES devices, as well as the reclassification petition we submitted, as we await a final classification ruling from FDA on CES devices.

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FDA and CES-A Call to Action

On Monday, August 8, 2011 the US Food and Drug Administration (FDA) published a Proposed Rule in the Federal Register (Volume 76, No. 152) regarding cranial electrotherapy stimulation (CES). This action is directed to the entire CES industry and not just Alpha-Stim CES. They have opened a 90 day public comment period on CES. This 90 day period is for FDA to receive public comment on the possibility of down-classifying CES from Class III to Class II or requiring Pre-Market Approval (PMA) in the USA. At the end of this comment period FDA will issue a final rule which will either down classify CES to Class II or will call for all CES manufacturers to prepare PMA Applications. While FDA conducts its review of these PMA’s, legally cleared CES devices may remain on the market in the USA.

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