Federal Register #2026-08425

FDA Classifies Brain Temperature Measurement System as Class II Medical Device

The Food and Drug Administration (FDA) has issued a final rule regarding the classification of a brain temperature measurement system: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - BrainTemp, Inc. is referenced as the requester for De Novo classification of the BrainTemp Neonate (BTNeo) System - Products/Services Requested: - Brain temperature measurement system (externally placed, prescription device) - No specific procurement of products or services is being solicited; this is a regulatory classification - Unique or Notable Requirements: - Device is classified as Class II (special controls) under 21 CFR Part 882 - Special controls required include: - In vivo and non-clinical performance testing - Electrical, mechanical, and thermal safety testing - Software documentation and validation - Biocompatibility evaluation - Usability evaluation - Specific labeling requirements - Device remains subject to premarket notification requirements under section 510(k) of the FD&C Act - Classification aims to ensure safety and effectiveness, reduce regulatory burdens, and enhance patient access to innovative devices

Description

The Food and Drug Administration (FDA) is classifying the brain temperature measurement system into class II (special controls). This device is an externally placed, prescription device intended to measure brain temperature. The classification aims to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices. Special controls include performance testing, safety testing, software validation, biocompatibility, usability evaluation, and specific labeling requirements.

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