title: Medical Devices; Obstetrical and Gynecological Devices;   Classification of the Intravaginal Culture System. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the intravaginal culture system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the intravaginal culture system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
mesh_terms: D046508:Culture Techniques / Q000145:classification* / Q000295:instrumentation*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004622:Embryo, Mammalian; D005260:Female; D005307:Fertilization in Vitro / Q000145:classification* / Q000295:instrumentation*; D005854:Germ Cells; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration; D014621:Vagina