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.