Federal Register #2026-07862

FDA Classifies Alzheimer's and Sleep Apnea Diagnostic Devices as Class II Medical Devices

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued a final rule classifying two medical devices into class II (special controls): - Alzheimer's Disease Pathology Assessment Test - In vitro diagnostic device for measuring biomarkers related to amyloid plaques and neurofibrillary tangles - Intended to aid in the diagnosis of Alzheimer's disease using FDA-approved PET imaging agents - Requires clinical data, performance testing, and specific labeling - Device for Sleep Apnea Testing Based on Mandibular Movement - Prescription device to evaluate sleep apnea by analyzing mandibular movement during sleep - Not a substitute for full polysomnography or apnea monitors - Requires clinical data, biocompatibility, performance data for electromagnetic compatibility and safety, software verification and validation, and specific labeling - No specific OEMs or vendors are named - No procurement or purchase quantities are specified - The rule is intended to enhance patient access to innovative devices and reduce regulatory burdens

Description

The Food and Drug Administration (FDA) is classifying the device for sleep apnea testing based on mandibular movement into class II (special controls). This device is a prescription device intended to aid in the evaluation of sleep apnea during sleep in patients suspected of having sleep breathing disorders by analyzing sensor readings of mandibular movement. It is not intended as a substitute for full polysomnography nor to be used as an apnea monitor. The classification aims to provide reasonable assurance of safety and effectiveness while enhancing patient access and reducing regulatory burdens.

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