FDA Reclassification of Cranial Electrotherapy Stimulation (CES)

Cranial Electrotherapy Stimulation (CES) used weak high-frequency electrical pulses to the head to as a treatment for neurological or psychiatric disorders.  The FDA recently issued an order re-classified how CES is regulated. Read the full FDA document here.

This comes after years of debate and meetings by the FDA, which may leave people following this activity confused, read more. Here’s the bottom line by our analysists at tdcs.com. And remember, CES is not transcranial Direct Current Stimulation (tDCS).

Bottom line: CES devices will stay on the market for Anxiety and Insomnia, but over the next year will not be marketed for Depression.

1) The FDA is effectivity removing depression as a cleared medical use for CES. There is some leeway time wise for existing CES devices marketed for Depression to keep marketing for Depression. But after that CES companies will need to file a Premarket Approval (PMA) to the FDA for depression use, that the FDA will then review. Since the FDA order just removed Depression as an indication, it seems that they will not then approve single devices. Unless manufacturers present data from new clinical trials. 

2) The FDA is allowing CES devices to be marketed for Insomnia and Anxiety, pending paperwork by each company.  The FDA seems ready to allow CES devices to keep being marketed for both Insomnia and anxiety, but each company will need to file paperwork largely based on showing devices are quality made. This step will likely see some devices where manufacturers are in active or cannot show compliance with medical device fabrication standards to drop out.

3) CES for Anxiety and Insomnia remain under prescription. Prescriptions must be obtained by patients through their caregivers or telemedicine services.

What does the FDA reclassification of CES mean to patients?  To the extent the FDA regulates marketing (advertisement) by companies to doctors and patients, the reclassification means companies won’t be allowed to market (websites, print material) CES for depression.  But, as long as companies file updated paperwork, they will be able to continue marketing CES for anxiety and depression. The FDA does not directly regulate doctors, so it remains up to individual physicians how they prescribe CES. The FDA does not directly regulate how patients use devices.

Update: tDCS.com provides access to top medical device Original Equipment Manufacturers (OEMs) and regulatory device expert. If you are a manufacturer interested in new technology or updating you existing product line, contact us. Tdcs.com is only an intermediary and does not provide any direct services or advice to manufacturers. 


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