The FDA agreed to downgrade headache treatment devices to a lower-risk classification, allowing new devices to reach the U.S. market with less-stringent oversight.
The devices went from Class III controls for high-risk devices, requiring premarket approval, to Class II controls for moderate-risk devices, reviewed through the fast-track 510(k) review pathway.
"FDA issued an order on November 20, 2012, classifying the Cefaly Device, into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II," according a notice in the Federal Register. "
The reclassification was requested by device maker STX-Med, the company behind the breakthrough Cefaly device that won FDA approval in March. STX-Med submitted Cefaly through the FDA’s de novo fast-track for novel technologies, allowing the company to land approval based on clinical trials spanning 67 patients and surveys of more than 2,300 respondents. Cefaly’s approval set the stage for other companies to request review under 510(k) by citing Cefaly as a substantially equivalent predicate device.
The FDA listed a series of special controls for new devices seeking regulatory review, based on potential risks of the technology, which include electrical or thermal hazards, ineffective treatment, misuse and adverse reactions to materials in the devices. The agency prescribed test for biocompatibility, electromagnetic compatibility, electrical and mechanical safety and other measures to ensure new devices are safe and effective.
The Cefaly system is a mobile, non-invasive nerve stimulator that delivers electrical energy via a plastic band worn across the forehead. The device aims to stimulate the trigeminal nerve, which doctors believe is associated with migraines. Patients aged 18 and up may use the technology for up to 20 minutes per day.