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# FDA Guidance on Device Thermal Effects
- URL: https://www.fdaweb.com/fda-guidance-on-device-thermal-effects/
- Published: 2024-03-14T12:00:00.000Z
- Updated: 2026-09-14T14:25:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156553

FDA has published a draft guidance, *Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling*, describing relevant information that should be provided in a premarket submission to support the evaluation of thermal effects of medical devices that produce local, regional, and/or systemic changes in tissue temperature due to their use. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluation-thermal-effects-medical-devices-produce-tissue-heating-andor-cooling?utm%5Fmedium=email&utm%5Fsource=govdelivery) provides recommendations on:

- evaluating thermal effects for various types of medical devices that produce changes in tissue temperature, either as an intended or unintended result of device use;
- when experimental methods, computational methods, and/or clinical studies may be appropriate to assess thermal effects; and
- information to include in premarket submissions to support the thermal effects evaluation.