The Food and Drug Administration (FDA) is classifying the vaginal hydrogel packing system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the vaginal hydrogel packing system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
US Federal Register - FDA Rules · September 10, 2026
Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System
FDA classifies vaginal hydrogel packing system as Class II device subject to special controls.
Published by US Federal Register - FDA Rules. HealthSignal links to the original document; the summary above is extracted from the source text.