Federal Register #FDA-2026-N-9904

FDA Classifies Vaginal Hydrogel Packing System as Class II Medical Device with Special Controls

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, has issued a final classification order for the vaginal hydrogel packing system as a class II medical device. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - BrachyFoam, Inc. (d/b/a Advaray) is the original manufacturer referenced for the BrachyGel Vaginal Hydrogel Packing System - Products/Services Requested: - Vaginal hydrogel packing system - Non-powered positioning device composed of a flexible container filled with hydrogel - Intended to reduce radiation dose to adjacent pelvic organs during radiation therapy - Unique or Notable Requirements: - Device must meet special controls including: - Clinical performance data - Non-clinical performance testing - Biocompatibility - Sterility - Shelf life - Specific labeling instructions - Controls are designed to mitigate risks such as unintended irradiation, infection, tissue damage, and patient discomfort - Classification reduces regulatory burdens for future devices of this type - No procurement or purchase of products or services is requested in this notice

Description

The Food and Drug Administration (FDA) is classifying the vaginal hydrogel packing system into class II (special controls). This device is a non-powered positioning device composed of a flexible container filled with hydrogel, intended to reduce radiation dose to adjacent pelvic organs during radiation therapy. The classification aims to provide reasonable assurance of safety and effectiveness, reduce regulatory burdens, and enhance patient access to innovative devices. Special controls include clinical performance data, non-clinical performance testing, biocompatibility, sterility, shelf life, and specific labeling requirements.

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