# Neurological Devices; Effective Date of Requirement for Premarket Approval of Cranial Electrotherapy Stimulators
> **Food and Drug Administration** · Final rule. · Published 1997-06-04 · Effective 1997-07-07 · 62 FR 30456
## Document
- **Document number:** 97-14597
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 62 FR 30456
- **CFR reference:** 21 CFR 882
- **Publication date:** 1997-06-04
- **Effective date:** 1997-07-07
- **HHS docket:** Docket No. 93N-0027
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1997/06/04/97-14597/neurological-devices-effective-date-of-requirement-for-premarket-approval-of-cranial-electrotherapy)
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