Consumer advocacy group Public Citizen petitioned the FDA to require a more stringent standard for cranial electrotherapy stimulator devices, after a panel of agency experts recommended that the products not be downgraded to a lower-risk category.
The FDA’s Neurological Devices Panel met last month to discuss whether CES devices need more regulatory oversight, concluding that "since the benefits did not outweigh the risks, the device should be Class III."
The devices, heretofore cleared for the U.S. market via the 510(k) process, apply electrical currents to the brain through the skin for the treatment of anxiety, depression, insomnia and pain.
"We strongly urge the FDA to accept the recommendations of the agency’s review staff and the majority of the NDP members and maintain the classification of CES devices as Class III, given the risks of harm that these devices present and the lack of sufficient evidence from well-designed clinical trials demonstrating their efficacy for depression, anxiety, or insomnia," Public Citizen wrote in a letter to Center for Devices & Radiological Health chief Dr. Jeffrey Shuren.
Public Citizen urged the federal watch dog agency agency to finalize a rule, proposed last August, that would require the devices to submit PMA applications, a measure staunchly opposed by CES device maker Alpha-Stim.
"The economic impact of the ruling is to impose a process that the FDA estimates will cost the company $1 million, for a product they approved over 30 years ago," the company wrote in November, when the agency set a date to consider the measure. "Alpha-Stim and its supporters find the ruling overly aggressive and in complete opposition to all the positive information found in studies that Alpha-Stim diligently provided."
The FDA published a final rule in 1995 requiring PMAs for CES devices, but revoked the decision in 1997 while maintaining Class III status on the products and allowing them to submit for market approval via 510(k), according to Public Citizen
In August 2011 the FDA proposed a new rule to require PMAs for CES, and device makers responded by proposing instead that the devices be given Class II status.
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