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FDA Registration of Fertility Scope:

“Fertility Scope falls under 21 CFR 862.1485 (luteinizing hormone test system) and are exempt from premarket notification [i.e., they do not require a 510(k)]. Title 21 of the Code of Federal Regulations (CFR) §862.1485 classifies this device as a luteinizing hormone test system, class 1. Class I devices are subject to general controls which are found at 21CFR 820. Fertility Scope, when used for determining ovulation cycle/identifying fertile period, would be exempt even if sold for over-the-counter use because a misdiagnosis as a result of using the devices would not be associated with high morbidity or mortality.”