Dive Brief:

• FDA on Thursday published a final order reclassifying cranial electrotherapy stimulator (CES) devices intended to treat anxiety or insomnia from Class III to Class II, a lower risk category.
• The order, which goes into effect 90 days from publication in the Federal Register, also requires the filing of a premarket approval application or a notice of completion of a product development protocol (PDP) for CES devices intended to treat depression.
• Further, the order clarifies the identification of a CES product to include it as a prescription device.

Dive Insight:

FDA published a proposed order in January 2016 after holding a meeting of the Neurological Devices Panel for a discussion of the CES device classification in February 2012. The agency also published an order in September 2009 that required submission of safety and effectiveness information on CES devices.

After considering the information and input from the 2012 panel meeting, as well as comments from the public, the agency determined that special and general controls under the classification will provide a reasonable assurance of safety and effectiveness for CES devices intended to treat anxiety and/or insomnia.

But the requirement of PMAs for CES devices intended to treat depression considered input from the device classification panel and over 300 comments on the proposed order, the agency said.

Several comments opposed keeping CES devices for the treatment of depression in Class III, while others questioned the call for requiring premarket approval arguing there are little to no safety or effectiveness concerns. But FDA said that based on the scientific evidence, it disagreed with those who called for the reclassification of CES for treatment of depression into Class II.

Depression levels did not differ significantly between patients who were treated with CES compared to those treated with placebo in most clinical trials, FDA said. Among the intended uses of insomnia, anxiety and depression, the evidence supporting the effectiveness of CES for treating depression was the weakest.

FDA also conducted an updated review of scientific literature and did not identify studies regarding the use of CES to treat depression as the primary diagnosis. The agency found a low number of adverse event reporting for CES devices. A new product code will be created for CES devices intended for the treatment of anxiety or insomnia.