Patients, Clinicians Advocate for Cranial Electrotherapy Stimulators

Dozens of commenters have written to FDA about its proposed order to reclassify cranial electrotherapy stimulator (CES) devices. FDA's proposal, issued in January, calls for CES devices to be recategorized from Class III devices to Class II devices when used to treat insomnia and/or anxiety, but to remain Class III devices when intended for a depression indication and be subject to the PMA pathway.

Comment period for the proposed order closes April 21 and so far, 85 public comments have been submitted. Most comments come from patients, parents, or providers who support a Class II reclassification of the devices for all indications, including depression. The devices were originally cleared through the 510(k) pathway, usually a less stringent regulatory hurdle than a PMA submission.

One supporter, who identified himself as a board certified psychiatrist in California, wrote in his comment, "In fact, CES is the safety brain stimulation available. We have had no injuries or even discontinuation due to adverse effects--none . . . The idea of CES as class III device is inappropriate and bizarre. It is clearly safer than many kitchen appliances. Anyone making a decision at the FDA can simply get a device and try it, if need--I can fly out and show you how simple and safe it is . . ."

Another comment came from a parent who uses a CES device for autistic catatonia in her son who has Down Syndrome. She wrote, "I agree with FDA's determination that is should be reclassified into Class II for the indications of anxiety and insomnia, but I feel that FDA should also reclassify the indication of depression in Class II. I have found no safety or effectiveness concerns utilizing this technology. Therefore, given the lack of risks to health and the proposed special control requirements, it is my opinion that all three indications should be reclassified to Class II."

Of course, not all comments supported reclassification. One person, who said he had tried a CES device, called it "grossly ineffective, expensive and in a very real way frustrating." 

This isn't the first time the subject of CES device classification has arisen. The potential for a move to Class II goes back to at least 2009, when CES device manufacturers sent FDA information supporting reclassification. In August 2011, FDA published a proposed rule calling for PMAs for CES devices. The agency was petitioned to consider reclassification to Class II for insomnia, depression, or anxiety. A meeting of the Neurological Devices Panel was convened in February 2012 and according to FDA, "the majority of the 2012 Panel did not think there was valid scientific evidence supporting effectiveness for treatment of insomnia, depression, or anxiety." The panel members noted a lack of device risk, yet a majority recommended maintaining Class III status. FDA points out in its latest proposed order that the 2012 panel didn't discuss reclassifying the CES device based on indication. 

In June 2014, the agency withdrew the PMA proposal, noting the more than 300 comments it received on the topic, many from commenters advocating for a Class II reassignment. At that time, FDA said it had determined there was enough information to establish special controls and that this combined with general controls gave reasonable assurance of safety and effectiveness for the insomnia and/or anxiety indication. 

Fisher Wallace Laboratories, makers of the Fisher Wallace Stimulator, recently sent an email to its contacts urging them to send comments to FDA. The company submitted its own comment last month, alleging "evidence of regulatory misconduct" that "gives the impression that the 2016 proposal is the result of inappropriate and sustained influence from Public Citizen and the Associate Commissioner for Public Health Strategy and Analysis, Peter Lurie, MD, PhD." The company, which filed a citizen petition in 2012 and amended it in 2016, wants an independent investigation by a party like HHS's Office of the Inspector General. FDA posted a letter of acknowledgement to the original petition in 2012, but has not yet issued a public response to this year's amendment.  Some details of this complaint, including concerns shared by at least one other CES manufacturer, were reported in two articles by MD+DI in 2012.

[Image courtesy of FISHER WALLACE LABORATORIES]