Neurological Devices; Effective Date of Requirement for Premarket Approval of Cranial Electrotherapy Stimulators

The Food and Drug Administration (FDA) is issuing a final rule to revoke a regulation requiring that a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) be submitted for the cranial electrotherapy stimulator (CES), a medical device. This action is being taken in order that FDA may reconsider whether the CES device may be reclassified from class III (premarket approval) into class II (special controls) or class I (general controls). Elsewhere in this issue of the Federal Register, FDA is issuing an order requiring manufacturers of these devices to submit information concerning their safety and effectiveness.