FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; RADIOLOGY DEVICES; CLASSIFICATION OF THE VAGINAL HYDROGEL PACKING SYSTEM

WASHINGTON, Sept. 10 -- Food and Drug Administration has issued a rule called: Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System.

The rule was published in the Federal Register on Sept. 10 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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 rea...