Data / Federal rules / 2025-21217
Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath
The Food and Drug Administration published this final rule in the Federal Register on November 26, 2025. It took effect on November 26, 2025.
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What the agency says
The Food and Drug Administration (FDA, the Agency, or we) is classifying the anchored esophageal sheath 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 the classification of the anchored esophageal sheath. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of 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.
Key facts
- Document number
- 2025-21217
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- November 26, 2025
- Takes effect
- November 26, 2025
- Dates
- This order is effective November 26, 2025. The classification was applicable on April 16, 2019.
- Docket
- Docket No. FDA-2025-N-4645
- Code of Federal Regulations
- 21 CFR 876
- Topics
- Medical devices
- Pages
- 3
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · Published in November 2025
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.