FDA lowers regulatory bar for neurostimulators to treat headache
|Cefaly headband for migraine treatment--Courtesy of Cefaly Technology|
They were previously classified as Class III devices requiring PMA approval because they were not "substantially equivalent" to another commercially available device before the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act. All such devices are automatically classified as Class III unless a firm successfully appeals to the FDA to issue a downgrade.
In this case, the change was prompted by Cefaly Technology (formerly STX-Med), which asked the agency to recognize its Cefaly device as a Class II product. The FDA agreed and granted it de novo approval in March. This change made Cefaly the first transcutaneous electrical nerve stimulation device available for use prior to the onset of pain, and more broadly, FDA's first approved migraine-preventing device.
Until the broader reclassification order becomes effective on Aug. 4, 2014, other devices similar to Cefaly will continue to be subject to Class III regulations--designed for high risk devices. Class II regulations are designated for low to moderate risk devices.
The bottom line is that starting in August, other devices deemed substantially equivalent to Cefaly will also secure marketing approval via the 510(k) clearance process. The devices will still be subject to special controls, but not to the lengthy clinical trials required for PMAs.
The special controls listed in the order include labeling, biocompatibility testing, safety testing and the availability of clinical performance data demonstrating that the product is safe and effective.
The reclassification signals growing acceptance and interest in electroceutical devices as well as nerve stimulation as a means to treat and prevent pain. For instance, startup electroCore is developing a vagus nerve stimulator that can prevent chronic migraine. Its Series A funding round recently reached the $50 million threshold.
- read the final order in the Federal Register
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