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 SmiraldoDiscussion 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.

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