Expand 510(k) Exemption to Muscle Sensors: Petition

Ohio State University assistant professor of physical medicine and rehabilitation Lynne Gauthier has petitioned FDA to expand 510(k) exemption status to all small and portable sensors that can be used for relaxation of muscular reeducation. The petition says that new sensors have recently become available that provide the same or better functionality as the battery-operated biofeedback devices that are currently exempt.

“Moreover,” Gauthier writes, “with the explosion of new technology, wearable biofeedback devices may not even require batteries in the near future. Thus, the current distinction requiring different levels of FDA oversight for devices that use battery power versus other biofeedback devices is outdated…. We propose that the exemption for battery powered biofeedback devices be expanded to include optical sensor devices as well.”