# Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Devices Intended To Treat Anxiety and/or Insomnia; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices Intended To Treat Depression
> **Food and Drug Administration** · Final amendment; final order. · Published 2019-12-20 · Effective 2019-12-20 · 84 FR 70003
## Document
- **Document number:** 2019-27295
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 84 FR 70003
- **CFR reference:** 21 CFR 882
- **Publication date:** 2019-12-20
- **Effective date:** 2019-12-20
- **HHS docket:** Docket No. FDA-2014-N-1209
## Abstract

The Food and Drug Administration (FDA) is issuing a final order to reclassify the cranial electrotherapy stimulator (CES) device intended to treat anxiety and/or insomnia, a preamendments class III device, into class II (special controls) and subject to premarket notification. FDA is also issuing this final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for CES devices intended to treat depression (product code JXK) and clarify the device identification of the CES device to include it as a prescription device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2019/12/20/2019-27295/neurological-devices-reclassification-of-cranial-electrotherapy-stimulator-devices-intended-to-treat)
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