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# Draft Guidance in Device Thermal Effects
- URL: https://www.fdaweb.com/draft-guidance-in-device-thermal-effects/
- Published: 2024-03-15T12:00:00.000Z
- Updated: 2026-09-14T14:25:32.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156569

*Federal Register* notice: FDA is making available a draft guidance entitled “Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating and/or Cooling.” The document describes 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). To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-03-15/pdf/2024-05584.pdf?ref=fdaweb.com).