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BiocompCHATibility
A NAMSA podcast series that addresses specific medical device evaluation scenarios and challenges.
On the latest instalment of the BiocompCHATibility podcast, our hosts are joined by Dr. Phil Smiraldo for his third feature on the podcast. The conversation throughout this episode focuses on the recently published FDA biocompatibility guidance document—issued on 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 fine print
- The Addition of Appendix G and how it can be utilized
- A general overview of other changes by the FDA from their previous document
*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.
Also be sure to check out our Biocompatibility Strategy Navigator.