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FDA Classifies Alzheimer's Pathology Test as Class II

FDA finalized classification of the Alzheimer's disease pathology assessment test as Class II (special controls), codifying the device type under 21 CFR 866.5840. The classification was applicable May 4, 2022, following De Novo review of Fujirebio Diagnostics' Lumipulse G β-Amyloid Ratio (1-42/1-40) device. Special controls identified in the order will apply to all devices of this generic type.

FDA Classifies Setmelanotide Eligibility Gene Variant Detection System Class II

FDA classified the setmelanotide eligibility gene variant detection system into class II (special controls) under 21 CFR 862.1164. The device is a qualitative in vitro diagnostic intended to detect germline variants within genes to identify patients eligible for setmelanotide treatment. Manufacturers of similar in vitro diagnostic devices should review special controls requirements.

Medical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia

FDA classified the digital therapy device for amblyopia as Class II with special controls. The device uses dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or improve visual acuity. This action codifies a prior De Novo classification from October 20, 2021, allowing other manufacturers to use this device as a predicate for 510(k) clearance.

Device for Sleep Apnea Testing Based on Mandibular Movement; Classification Into Class II

FDA has classified the device for sleep apnea testing based on mandibular movement into Class II (special controls), codifying the classification at 21 CFR 868.2376. The device is a prescription device intended to aid in evaluation of sleep apnea during sleep in patients suspected of having sleep breathing disorders. This De Novo classification, originally issued to Sunrise SA on January 7, 2022, establishes special controls that, combined with general controls, provide reasonable assurance of safety and effectiveness.