Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures
- Published
- Sep 10, 2026
- Effective
- Sep 10, 2026
- Citation
- 91 FR 57500
- Docket
- Docket No. FDA-2026-N-9910
- Agencies
- DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
Final amendment; final order.
Summary
The Food and Drug Administration (FDA) has placed a new type of device—used to regulate temperature and protect the esophagus during cardiac ablation procedures—into “Class II” with specific special controls. This classification means the device is considered to have a moderate level of risk, and the FDA has identified particular performance standards and labeling requirements that manufacturers must meet. The goal is to ensure the device is safe and effective while making it easier for innovative products to reach patients without unnecessary regulatory hurdles. The rule was issued by the Department of Health and Human Services, through the FDA, and it applies to manufacturers, distributors, and health‑care providers of the temperature‑regulation device. By setting clear, enforceable standards, the agency aims to protect patients undergoing heart‑rhythm procedures and to give companies a predictable pathway to market. The regulation took effect on September 10, 2026, the same day it was published in the Federal Register (91 FR 57500). Because this is a final rule, there is no further public comment period. Companies that produce or plan to market the device must now comply with the specified special controls to obtain FDA clearance or approval for sales in the United States.
AI-generated summary — verify against the Federal Register text.
Official abstract
The Food and Drug Administration (FDA) is classifying the temperature regulation device for esophageal protection during cardiac ablation procedures 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 temperature regulation device for esophageal protection during cardiac ablation procedures. 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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