In October 2020 FDA released a new draft biocompatibility guidance document which focuses on the biological evaluation of devices in contact with intact skin. As a draft document, it is therefore open for comments and possible changes. Release of this guidance signifies another step from FDA toward their 3R animal initiative (reduce, refine, and replace animal use in testing when feasible).
Whitepaper
WHITEPAPER
The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list
January 5, 2021 | By: Thor Rollins
Thor Rollins
RM (NRCM)
Biocompatibility 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...
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