Electrical Stimulators Need High-Risk Rating, Says FDA Panel

Allison Shelley

February 17, 2012

February 17, 2012 — A US Food and Drug Administration (FDA) advisory committee has voted against 3 petitions to reclassify cranial electrotherapy stimulators. The Neurological Devices Panel is instead recommending the agency maintain high-risk class 3 standing for these devices.

Existing regulations define cranial electrotherapy stimulation as a device that applies electrical current to a patient's head to treat insomnia, depression, or anxiety. There are presently no additional guidelines about the characteristics of the stimulation or the placement of the electrodes. There is also no performance standard for cranial electrotherapy.

"The majority of committee members felt that in light of the available scientific evidence for efficacy, the devices should remain class 3," panel chair Robert Hurst, MD, from the University of Pennsylvania in Philadelphia, said at the meeting. "A couple members said class 2 would be feasible, and another said this should be the case for the treatment of anxiety only."

A device is considered class 2 if there is sufficient information to establish a reasonable assurance of safety and efficacy. A class 3 designation is for devices that have insufficient information or are life-supporting, life-sustaining, or present an unreasonable risk for illness or injury.

Industry representative David Mueller, MS, from American Medical Systems in Minnetonka, Minnesota, said a reclassification was in order, as did patient representative Michelle Carras, from Johns Hopkins University in Baltimore, Maryland.

Most committee members agreed that the safety of these stimulators has been well established. Those in favor of reclassifying the stimulators argued that, with a low risk and possible benefit, it makes sense to open access.

Richard Fessler, MD, from Northwestern University in Evanston, Illinois, was among those voicing this opinion. "The rigors we are applying seem extreme to say the least.... Silly, even," he said.

The FDA issued a proposed rule in August 2011 that, if made final, would classify cranial electrotherapy stimulators as high risk, requiring premarket approval.

Petitions Filed

Three companies filed petitions, including Electromedical Products International, Fisher Wallace Laboratories, and Neuro-Fitness.

After the committee presented its consensus, Scott Elder, vice president and general counsel at Electromedical Products International, voiced his disappointment in the process.

"I'd like to point out the inherent unfairness in this. We received just yesterday notice of studies to be excluded from our presentation. I believe that had you seen all of the data, you would have come to a different conclusion," he told the panel. "We had just 1 day to prepare after the deletions of good research."

Speaking on behalf of Fisher Wallace Laboratories, Stephen Xenakis, MD, said he is concerned the panel is overly concerned about scientific rigor and not worried enough about treatment-resistant patients with few options. "We have large groups of patients who are less than 50% satisfied with their current treatments," Dr. Xenakis said. "With a denominator like this, the numerator is magnified, and isn't a reasonable risk justified?"

Toward the end of the meeting, a member of the public grabbed a microphone and stated, "I'd like to go on record, I am extremely unsatisfied." The man was instructed by the committee chair and the FDA that the time for public comments had expired. His microphone was then turned off, although he continued speaking for some time. His final comments were inaudible.

Consumer representative Anne Alexandrov, PhD, spoke next. "To the manufacturers of these devices, and to the patients who have received care, you now have a fantastic opportunity before you to do some compelling research to demonstrate that they are effective and safe. Well-designed trials will be critical moving forward, and this is very important for consumers."

Neurological Devices Panel Meeting. February 10, 2012. Gaithersburg, Maryland.

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