The US Food and Drug Administration (FDA) wants medical device sponsors to test products that may cause changes in tissue temperatures, regardless of whether they heat or cool the tissue and whether the change in temperature is intentional. The agency provided details on how to conduct testing and gather data, and recommended sponsors talk to regulators early.
On 15 March, FDA published a draft guidance outlining the agency’s recommendations for conducting testing, gathering data, and presenting results in premarket applications to reviewers on medical devices that may cause tissue temperature changes…
