Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling: Draft Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Published
March 15, 2024
Last updated
March 14, 2024
Description
Draft guidance document by FDA and industry for evaluating thermal effects of medical devices that heat or cool tissues, focusing on safety and efficacy.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)