Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating and/or Cooling; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating and/or Cooling." FDA is issuing this draft guidance document to describe relevant information that should be provided in premarket submissions to support the evaluation of thermal effects of medical devices that produce local, regional, and/or systemic changes in tissue temperature (i.e., heating and/or cooling) due to their use. The recommendations in this draft guidance reflect current review practices and are intended to promote consistency and facilitate efficient review of thermal effects data in premarket submissions for these devices. This draft guidance is not final nor is it for implementation at this time.