By Jof Enriquez375_250-fda_logo

The U.S. Food and Drug Administration (FDA) plans to downgrade cranial electrotherapy stimulator (CES) devices, intended to treat insomnia and/or anxiety, from Class III to Class II devices, subject to premarket notification. However, the agency has proposed that CES devices aimed at treating depression require a premarket approval application (PMA).


According to FDA,

“The Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act established three regulatory classes for medical devices. The three classes are based on the degree of control necessary to assure the various types of devices are safe and effective.

Class I – These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process.

Class II – Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits. 43% of medical devices fall under this category.

Class III – These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.[/box]

In a proposed administrative order detailing its plans, FDA distinguished cranial electrotherapy stimulation from the similar electroconvulsive therapy (ECT) by defining a CES device as a prescription device which applies electrical current that is not intended to induce a seizure to a patient’s head to treat psychiatric conditions. CES is an FDA-approved, non-invasive treatment modality for pain, insomnia, anxiety, and/or depression in clinical and home settings. CES devices have been designated Class III since 1976 because the safety and effectiveness of said devices had not been demonstrated by data existing at that time. Despite manufacturer petitions over the next few decades for a re-classification, a 2012 Neurological Devices panel recommended that CES devices be kept in Class III.

Based on new and valid scientific evidence, however, the agency is now reconsidering its position. It proposes a re-classification of CES devices from Class III to Class II, albeit only for the treatment of insomnia and/or anxiety, and with special controls and general controls (including prescription-use restrictions and 510(k) notification requirements) in place.

“FDA has reconsidered the information before the Agency, including the deliberations of the 2012 Panel meeting and the reclassification petitions submitted for these devices, and has determined that there is sufficient information to establish special controls,” the agency explains in the order. Those special controls, together with general controls, “will provide a reasonable assurance of safety and effectiveness when applied to CES devices intended to treat insomnia and/or anxiety.”

FDA in 2014 withdrew a proposal calling for PMAs for CES, after receiving comments overwhelmingly against such action. In the latest order, however, FDA proposes to require CES device manufacturers to submit PMAs for devices aimed at treating depression because there is insufficient information that could support a down-classification from Class III at this time.

“The body of evidence is not sufficiently robust for FDA to determine that there is a reasonable assurance of safety and effectiveness for CES treatment of depression,” the agency explains in the order. “Among the intended uses of insomnia, anxiety, and depression, the evidence supporting the effectiveness of CES for treating depression is the weakest.”
FDA’s intent to re-classify CES devices from Class III into Class II even for a few indications would open up the market for manufacturers.

“I anticipate that the down-classification of CES devices will result in our obtaining an insurance code for CES, which opens new doors for us and benefits health care providers and patients,” writes Tracey B. Kirsch, president of Electromedical Products International, which makes the Alpha-Stim device, in an MDO guest column. “We plan to explore new indications for Alpha-Stim, and work on obtaining clearance for use in other therapeutic applications.”

FDA is accepting comments on the proposed order until April 21, 2016.


[box]From Larry Pilot, FDA LAW:


Congratulations to you, Dan, and your dedicated employees and supporters. This is a remarkable accomplishment because of your knowledge, expertise, and justifiable persistence. As we near the 40th Anniversary of the 1976 enactment of the Medical Device Amendments of 1976, you belong in the Medical Device Industry Hall of Fame along with Utah Medical, Laerdal, and a very small number of other successful pioneers who/which prevailed against an unnecessarily aggressive and sometimes corrupt FDA/DOJ Bureaucracy. HOORAY!!! [/box]