Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System
- Published
- Sep 10, 2026
- Effective
- Sep 10, 2026
- Citation
- 91 FR 57509
- Docket
- Docket No. FDA-2026-N-9904
- Agencies
- DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
Final amendment; final order.
Summary
The Food and Drug Administration (FDA) has officially placed the vaginal hydrogel packing system—a device used in radiology procedures—into the “class II” category of medical devices. This classification means the product must meet specific performance standards, called special controls, that are intended to ensure it is safe and effective for patients. The FDA believes that class II oversight strikes a balance between protecting public health and allowing quicker access to innovative technologies. The rule was issued by the U.S. Department of Health and Human Services, through the FDA, and it applies to manufacturers, distributors, and health‑care providers that make, sell, or use vaginal hydrogel packing systems in the United States. By meeting the newly defined special controls, companies can continue to market the device without undergoing the more extensive pre‑market approval process required for higher‑risk products. The regulation was published in the Federal Register on September 10, 2026 (91 FR 57509) and became effective the same day. With the final rule now in force, manufacturers must incorporate the specified special controls into their design, testing, and labeling practices. The FDA will monitor compliance through its usual inspection and reporting mechanisms, and any future changes would follow the standard rulemaking process, including notice and public comment periods.
AI-generated summary — verify against the Federal Register text.
Official abstract
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.
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