The Food and Drug Administration (FDA) is classifying the esophageal thermal regulation device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the esophageal thermal regulation device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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Medical Devices; Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device
The Food and Drug Administration (FDA) is classifying the esophageal thermal regulation device into class II (special controls). The special controls that will apply to the devi...
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80 FR 49895
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“Medical Devices; Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device,” thefederalregister.org (August 18, 2015), https://thefederalregister.org/documents/2015-20317/medical-devices-cardiovascular-devices-classification-of-the-esophageal-thermal-regulation-device.