FDA Okays Esophagus Chill Pill for Heart Procedures
Published Date: 9/10/2026
Rule
Summary
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.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
New Special Controls and Testing Requirements
The FDA requires specific special controls for these devices, including clinical performance testing (including evaluation of reduction in esophageal injury and any procedure effects), animal performance testing, non-clinical testing (mechanical integrity, temperature change rates, accessory compatibility), sterility and shelf-life testing, biocompatibility evaluation, and required labeling such as a summary of clinical testing and shelf life. These controls are part of the Class II codified rule at 21 CFR 870.5720.
Class II Clears Path to Patient Access
The FDA officially classified the temperature regulation device for esophageal protection during cardiac ablation procedures as Class II (special controls). FDA says this classification provides reasonable assurance of safety and effectiveness and will enhance patients' access to beneficial innovation by reducing regulatory burdens; the order is effective September 10, 2026 and the classification was applicable on September 13, 2023.
Creates Predicate Pathway for Future Devices
By classifying this device through the De Novo process, FDA allows this device type to serve as a predicate device for future products, enabling other sponsors to use the less-burdensome 510(k) pathway instead of De Novo or premarket approval. FDA notes the De Novo classification process requires FDA to classify the device by written order within 120 days under section 513(f)(2).
Device Subject to 510(k) Premarket Notification
FDA states that, at this time, it has not determined that temperature regulation devices for esophageal protection are exempt from section 510(m), so this device type is subject to premarket notification under section 510(k) of the FD&C Act. Sponsors must therefore submit a 510(k) to reasonably assure safety and effectiveness unless FDA later exempts the device type.
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Key Dates
Department and Agencies
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