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 require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the cranial electrotherapy stimulator (CES), a medical device. This action is being taken under the Medical Devices Amendments Act of 1976. Commercial distribution of this device must cease, unless a manufacturer or importer has filed with FDA a PMA for its version of the cranial electrotherapy stimulator device within 90 days of the effective date of this regulation.