Opportunity
Federal Register #Docket No. FDA-2026-N-9910
FDA Classifies Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures as Class II
Buyer
Food and Drug Administration
Posted
September 10, 2026
Identifier
Docket No. FDA-2026-N-9910
NAICS
339112, 334510
This FDA final order establishes a regulatory classification for temperature regulation devices used to protect the esophagus during cardiac ablation procedures. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Device Classification: - Temperature regulation device for esophageal protection during cardiac ablation - Classified as Class II (special controls) under 21 CFR Part 870, Section 870.5720 - Products/Services Requested: - No specific products, part numbers, or quantities are mentioned - Unique/Notable Requirements: - Devices must be placed in the lumen of the esophagus to regulate temperature and reduce injury risk - Special controls include: - Clinical, animal, and non-clinical performance testing - Biocompatibility, sterility, and shelf life validation - Specific labeling requirements - Classification aims to ensure safety and effectiveness, reduce regulatory burdens, and improve patient access to innovative devices - OEMs and Vendors: - No specific OEMs or vendors are named in the notice - No procurement or purchase activity is announced; this is a regulatory classification action
Description
The Food and Drug Administration (FDA) is classifying the temperature regulation device for esophageal protection during cardiac ablation procedures into class II with special controls. This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury during cardiac ablation procedures by controlling the temperature of the esophagus. The classification aims to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices. Special controls include clinical, animal, and non-clinical performance testing, biocompatibility, sterility, shelf life, and specific labeling requirements.