Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061 (HFA-305)
Rockville, Maryland 20852
May 6, 2013
Comments of Members of the Patient, Consumer, and Public Health Coalition
on Proposed Order
Regarding Cranial Electrotherapy Stimulator Devices
[Docket No. FDA-2013-N-0195]
As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA requiring the premarket approval (PMA) process for cranial electrotherapy stimulator devices because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness.
Cranial electrotherapy stimulator for the treatment of depression, anxiety, and insomnia.
We strongly support FDA’s Class III PMA requirement for this device because currently available data clearly indicate that it is ineffective and poses unreasonable health risks. Eighty-eight published studies on cranial Electrotherapy Stimulators (CES) “concluded that the device has not been shown to be effective.”1
On February 10, 2012, the Neurological Devices Panel recommended that CES for treatment of depression, anxiety, and insomnia should remain in Class III requiring PMAs. We agree with the panel. We are aware that FDA has received petitions to reclassify the device into Class II for the treatment of depression, anxiety, and insomnia in adult substance abuse patients. We oppose the petitions, because these devices should not be on the market unless a sponsor can prove that they are safe and effective. We note that one of the petitioners’ devices had a Class 2 recall in 2008 involving 3,000 CES devices because they did not have FDA “clearance for the .35Hz/.45Hz frequency option on [the] device.”
A down classification from Class III to Class II (and 510(k) clearance) would not require a sponsor to prove that their product is safe or effective. Even if the device were cleared by the 510(k) process for a narrower use, it could easily be used off-label for treatments that require a PMA. In other words, down-classification for any indication would create a loophole which would allow manufacturers to avoid the more rigorous PMA review process.
Members of the Patient, Consumer, and Public Health Coalition strongly support the FDA recommendation to require the PMA review process for cranial electrotherapy stimulator devices. They have substantial health risks and lack “valid scientific evidence to demonstrate reasonable assurance of the safety and effectiveness.”
Center for Medical Consumers
Connecticut Center for Patient Safety
National Research Center for Women & Families
National Women’s Health Network
The TMJ Association
For more information, contact Paul Brown at (202) 223-4000 or firstname.lastname@example.org
 Federal Register (April 4, 2013). Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose. [Docket No. FDA-2013-N-0195]
 U.S. Food and Drug Administration (April 8, 2008). Medical & Radiation Emitting Device Recalls. Class 2 Recall CES Ultra. Recall number Z-0712-2008. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65660.