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. Read the rest of this entry »
