# Neurological Devices; Effective Date of Requirement for Premarket Approval of Cranial Electrotherapy Stimulators
> **Food and Drug Administration** · Final rule. · Published 1995-08-24 · Effective 1995-08-24 · 60 FR 43967
## Document
- **Document number:** 95-20960
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 60 FR 43967
- **CFR reference:** 21 CFR 882
- **Publication date:** 1995-08-24
- **Effective date:** 1995-08-24
- **HHS docket:** Docket No. 93N-0027
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1995/08/24/95-20960/neurological-devices-effective-date-of-requirement-for-premarket-approval-of-cranial-electrotherapy)
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