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The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list

January 21, 2021

11:00 am MST

In October of 2020, the FDA released a new draft biocompatibility guidance document. This new draft focuses on the biological evaluation of devices in contact with intact skin. This document signifies another step from the FDA toward their 3R animal initiative (reduce, refine, and replace animal use in testing when feasible).

In this webinar, we will go into detail on this new FDA draft document.

  • We will give flavor on why the FDA released this guidance and what it means for skin-contacting medical devices.
  • We will look at the list of materials that fall into the guidance (the nice list) and then the ones that are excluded (the naughty list).
  • We will also cover what should be included in your submission of these materials to make sure you have success with your FDA submission.
Thor Rollins

Thor Rollins

Toxicology and E&L Expert

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...