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Product safetyFDAUnited StatesImports

Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System

10 September 2026

In plain English

FDA is classifying the vaginal hydrogel packing system as a class II medical device subject to special controls, as set out in this order.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
10 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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 thi
The full text is at the source

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