In the August 18, 2015, Federal Register, FDA published its classification of the esophageal thermal regulation device into class II (special controls) medical device. Biocompatibility testing, labeling, and other evaluations will be required to mitigate identified risks of injury, adverse tissue reactions, and hypo/hyperthermia.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
