# Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device
> **Food and Drug Administration** · Final amendment; final order. · Published 2025-11-26 · Effective 2025-11-26 · 90 FR 54232
## Document
- **Document number:** 2025-21218
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 90 FR 54232
- **CFR reference:** 21 CFR 882
- **Publication date:** 2025-11-26
- **Effective date:** 2025-11-26
- **HHS docket:** Docket No. FDA-2025-N-4680
## Abstract

The Food and Drug Administration (FDA, the Agency, or we) is classifying the field generator positioning device into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices in part by reducing regulatory burdens.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2025/11/26/2025-21218/medical-devices-neurological-devices-classification-of-field-generator-positioning-device)
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