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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.

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.