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

**Action Urgency Score:** 30/100

| Field | Value |
|---|---|
| Agency | Health and Human Services Department; Food and Drug Administration |
| Type | Final rule |
| Action | Final amendment; final order. |
| Published | 2026-09-10 |
| Effective | 2026-09-10 |
| Significant | No |
| CFR parts | 21 CFR 892 |
| 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 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 regul |
| Document number | 2026-18427 |

## Why this score
- Final rule.

Source: Federal Register API (Office of the Federal Register) (https://www.federalregister.gov/documents/2026/09/10/2026-18427/medical-devices-radiology-devices-classification-of-the-vaginal-hydrogel-packing-system). Last refreshed: 2026-11-04T21:40:49.974Z.
Data from the Federal Register API; the published Federal Register document is authoritative. Informational only, not legal advice.