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Whitepaper

WHITEPAPER

The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list

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).

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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Biological Evaluation of Skin-Contacting Medical Devices Whitepaper
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Whitepaper

WHITEPAPER

The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list

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).

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...

Complete the following information to access the whitepaper

Biological Evaluation of Skin-Contacting Medical Devices Whitepaper
Header Artwork
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Whitepaper

WHITEPAPER

The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list

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).

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...

Complete the following information to access the whitepaper

Biological Evaluation of Skin-Contacting Medical Devices Whitepaper
Header Artwork
Header Artwork

Whitepaper

WHITEPAPER

The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list

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).

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...

Complete the following information to access the whitepaper

Biological Evaluation of Skin-Contacting Medical Devices Whitepaper
Header Artwork
Header Artwork

Whitepaper

WHITEPAPER

The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list

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).

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...

Complete the following information to access the whitepaper

Biological Evaluation of Skin-Contacting Medical Devices Whitepaper