FDA withdraws proposed PMA rule for cranial electrostimulators

Fisher Wallace Stimulator--Courtesy of Fisher Wallace

The U.S. Food and Drug Administration has opted not to require a full premarket approval application for cranial electrotherapy stimulators (CES). These devices apply electrical current to a patient's head to treat insomnia, depression or anxiety.

The agency had proposed in August 2011 that these devices require a full PMA. In addition, the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) also required that certain devices, including CES, follow the PMA path.

However, the agency said it received four separate comment submissions requesting that CES devices be reclassified from Class III, which requires a PMA, to Class II, which requires only a 510(k) application. In addition it considered the deliberations of a 2012 meeting of the FDA Neurological Devices Panel.

The agency referred to unspecified "special controls," which along with general controls, would be sufficient to ensure the safety and effectiveness of CES devices.

"This decision is a watershed moment in the history of CES and demonstrates that the FDA is committed to supporting scientifically proven alternatives to drug therapy for the treatment of insomnia, anxiety and depression--the three symptoms most common to sufferers of post-traumatic stress, many of whom served our country in Iraq and Afghanistan," President of Fisher Wallace Laboratories Chip Fisher told Sleep Review. "We applaud the agency's position and look forward to the months that follow as the regulatory process unfolds."

Fisher Wallace markets a cranial electrotherapy device that received 510(k) clearance from FDA in 1991 for the treatment of depression, anxiety, insomnia and chronic pain.

- here is the Federal Register notice
- and the article by Sleep Review

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