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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.