The Food and Drug Administration (FDA) has agreed to propose approval and reclassification of cranial electrotherapy stimulation (CES) devices for the treatment of insomnia, depression, and anxiety. In a document to be published tomorrow, the FDA says it is withdrawing the proposed rule it issued in the Federal Register of August 8, 2011, and the proposed order it issued in the Federal Register of April 4, 2013, in part. In those documents, FDA proposed to require the filing of a premarket approval application or a notice of completion of a product development protocol for the class III preamendment device, cranial electrotherapy stimulator. In response to information received in response to these two proposed actions, FDA is withdrawing the proposed rule and proposed order.
“This decision is a watershed moment in the history of CES and demonstrates that the FDA is committed to supporting scientifically proven alternatives to drug therapy for the treatment of insomnia, anxiety and depression—the three symptoms most common to sufferers of post-traumatic stress, many of whom served our country in Iraq and Afghanistan,” says Chip Fisher, president of Fisher Wallace Laboratories, which makes the Fisher Wallace Stimulator. “We applaud the Agency’s position and look forward to the months that follow as the regulatory process unfolds.”
He adds that there are several steps which must occur before the Agency officially approves CES, including the FDA’s formal proposal for reclassification and the public comment period following such a proposal. “But today the FDA stated that it has determined ‘that there is sufficient information to establish special controls, and that these special controls, together with general controls, will provide a reasonable assurance of safety and effectiveness for CES devices…FDA plans to issue a proposed order in the future for the reclassification of the CES device into Class II,’” Fisher says.
Lawrence Paros, President of Neuro-Fitness LLC manufacturer of the CES Ultra ( www.cesultra.com) , concurred: “This is the culmination of almost a half century of effort to gain credence for an effective non-pharmacological modality for the treatment of stress and stress-related disorders. It has the potential to revolutionize the treatment of substance abuse and PTSD with none of the negative side effects of drugs and provide a safe and effective low cost approach to medical issues besetting millions of our citizens. . The FDA is to be commended for its foresight in verifying its legitimacy and the science behind it.”