Data / Federal rules / 2025-21218
Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device
The Food and Drug Administration published this final rule in the Federal Register on November 26, 2025. It took effect on November 26, 2025.
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What the agency says
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.
Key facts
- Document number
- 2025-21218
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- November 26, 2025
- Takes effect
- November 26, 2025
- Dates
- This order is effective November 26, 2025. The classification was applicable on July 10, 2020.
- Docket
- Docket No. FDA-2025-N-4680
- Code of Federal Regulations
- 21 CFR 882
- Topics
- Medical devices
- Pages
- 3
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · Published in November 2025
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.