Federal Register #2026-07860

FDA Classifies Alzheimer's Disease Pathology Assessment and Sleep Apnea Devices as Class II Medical Devices

The Food and Drug Administration (FDA), through its Center for Devices and Radiological Health, has issued a final order classifying two medical devices into Class II (special controls): - Alzheimer's disease pathology assessment test - In vitro diagnostic device intended to measure analytes in human specimens to assess amyloid plaques or neurofibrillary tangles - Aids in the diagnosis of Alzheimer's disease in patients with cognitive impairment - Requires compliance with special controls for safety and effectiveness, including design verification, clinical performance studies, labeling, and premarket notification (510(k)) - Not intended as a stand-alone test - Fujirebio Diagnostics, Inc. is mentioned as a device sponsor for the Lumipulse G β-Amyloid Ratio (142/140) device - Device for sleep apnea testing based on mandibular movement - Medical device for sleep apnea testing using mandibular movement - Also classified as Class II with special controls - No specific product part numbers (except 866.5840 for the Alzheimer's test) or purchase quantities are provided - The classification aims to reduce regulatory burdens and enhance patient access to innovative devices - Unique requirements include compliance with special controls for safety and effectiveness - No procurement or award is being announced; this is a regulatory classification action

Description

The Food and Drug Administration (FDA) is classifying the Alzheimer's disease pathology assessment test into class II (special controls). This in vitro diagnostic device measures analytes in human specimens to assess amyloid plaques or neurofibrillary tangles in patients with cognitive impairment, aiding in the diagnosis of Alzheimer's disease. The classification aims to provide reasonable assurance of safety and effectiveness while enhancing patient access to innovative devices by reducing regulatory burdens. The device requires premarket notification under section 510(k) and must comply with special controls outlined by the FDA.

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