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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.

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.

Sky-Spray LLC Requests Extension of Agricultural Drone Exemption No. 22701

Sky-Spray LLC has filed a petition with the FAA requesting renewal of Exemption No. 22701, which authorizes commercial agricultural services using unmanned aircraft systems weighing more than 55 pounds. The petition seeks continued exemption from multiple provisions of 14 CFR Parts 61, 91, and 137, as well as authority under 49 U.S.C. § 44807. The exemption covers pilot certification requirements, aircraft airworthiness standards, flight rules, and agricultural aircraft operations rules.