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FDA Releases New Draft Guidance for Biocompatibility of Devices in Contact with Intact Skin

On October 15, 2020, the U.S. Federal Food and Drug Administration (FDA) released a new draft guidance, “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin,” which is intended to add or supersede applicable sections of the 2016 biocompatibility guidance (recently updated in 2020), “Biological Evaluation of Medical Devices-Part 1: Evaluation and … Continued