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BiocompCHATibility Podcast
New FDA Biocompatibility Guidance – Let’s Discuss

New FDA Biocompatibility Guidance – Let’s Discuss

BiocompCHATibility vor 2 Jahren

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38:01

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

On the latest installment of the BiocompCHATibility podcastis
episode, our hosts are joined by Dr. Phil Smiraldo for his third
feature3-peat episode on the podcast.

The conversation throughout this episode focuses and we discuss
on the new recently published FDA biocompatibility guidance
document —issued onn September 7, 2023.

“My favorite nuance is that annex A has slightly been updated
because now the X’s and O’s are almost all gone.” – Don Pohl

“Of these materials, you touch them every day, and your clothes
are made out of them... Why would we need to do biocompatibility
testing as a device? At a high level, that is what [(Attachment
G)] says.” – Don Pohl

“There are a few caveats, such as devices made for neonates… they
are going to want to see the data. And similar type wording for
pregnant woman.” – Phil Smiraldo

“We are not saying it’s never possible, but you’re going to have
to really convince us if you only look at Part 1 and not our
guidance” – Sheri Krajewski-Bibins

“One thing that I do like about this FDA document is it uses the
same language from the ISO 10993 series.” – Phil Smiraldo

Discussion points include:

Verbiage updates to legally market devices and the fineprint.

The Addition of Appendix G and how it can be utilized.

A general overview of other changes by the FDA from their
previous document.