The U.S. Food and Drug Administration (FDA) has published a draft guidance on assessing the thermal effects of medical devices that intentionally or unintentionally produce tissue temperature changes.
Issued in March, the draft guidance, “Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling,” details the information that device manufacturers should include in their premarket submission to the FDA to document and support its evaluation of the thermal effects of medical devices associated with their use.
According to the draft guidance, medical devices that fall under the scope of the guidance include those “that deliver radiofrequency, microwave, light, or other forms of electromagnetic energy, devices that deliver ultrasound, electroporation devices, devices that produce temperature changes through contact, and devices where electrical components can potentially heat surrounding tissue during use.”
Comments on the draft guidance can be filed electronically through the Regulations.gov website. Comments must be submitted by May 14th.
Guidance documents issued by the FDA and other agencies are intended solely to provide insight into the current thinking of regulators and should be viewed only as recommendations and not requirements.
Read the FDA’s draft guidance on the evaluation of thermal effects of medical devices.
