Medical Devices; Neurological Devices; Classification of the Brain Temperature Measurement System
fda-device · Food and Drug Administration · Rule · Published 2026-04-30 · Effective 2026-04-30 · 91 FR 23163
Document
Document number
2026-08425
Federal Register citation
91 FR 23163
CFR reference
21 CFR 882
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2026-04-30
Effective date
2026-04-30
HHS docket
Docket No. FDA-2026-N-4269
Abstract
The Food and Drug Administration (FDA) is classifying the brain temperature measurement system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the brain temperature measurement system. We are taking this action because we have determined that classifying the device into class II 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.