FDA Ends Approval Requirement for Headache Treatment Device

The Food and Drug Administration is formally reclassifying transcutaneous electrical nerve stimulators as Class II devices that do not require premarket approval, in an order that codifies a reclassification that took effect March 11. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. FDA reclassified them in response to a request from STX-Med related to the Cefaly Device. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to testing, biocompatibility, and labeling. The devices will not be exempt from premarket notification requirements.