Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device
fda-device · Food and Drug Administration · Rule · Published 2025-11-26 · Effective 2025-11-26 · 90 FR 54232
Document
Document number
2025-21218
Federal Register citation
90 FR 54232
CFR reference
21 CFR 882
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
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.