GUIDANCE DOCUMENT
Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling Draft Guidance for Industry and Food and Drug Administration Staff March 2024
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2024-D-0664
- Docket Number:
- FDA-2024-D-0664
- Issued by:
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Guidance Issuing OfficeCenter for Devices and Radiological Health
This draft guidance document provides the FDA’s recommendations on testing to assess thermal effects of medical devices. This guidance applies to devices that produce tissue temperature changes (i.e., heating and/or cooling) as an intended or unintended consequence of device use. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of thermal effects data in submissions for these devices.