Listener Mailbag – We Answer Your Questions
In this episode, our hosts answer your questions about biocompatibility. After 15 episodes of discussing what we think is important surrounding this topic, we asked for your questions and created this special episode to answer them.
“A toxicological risk assessment is the process of focusing on the risk associated with the chemicals that are in or may come out of a device, that’s your primary focus.” – Don Pohl
“The first step to investigation is trying to understand root cause […] what went into to my device that might cause this response.” – Don Pohl
“I love the ever changing environment, and I’m excited about us (the industry) getting better at performing evaluations that minimize unnecessary testing,” – Sheri Krajewski-Bibins
“The reality is, if you look at the grand scheme of things, it (biological evaluation of medical devices) is relatively new in terms of what we are doing – it’s constantly evolving and changing.” – Don Pohl
Discussion points include:
- Updates on In Vitro alternative testing
- How to handle unexpected biocompatibility results
- What genotoxicity methods are preferred by the FDA
- Alternative extraction temperatures accepted by the FDA
- Differences between a toxicological risk assessment and a biological risk assessment
The future of biological safety evaluations – an exciting outlook
Also be sure to check out our Biocompatibility Strategy Navigator.