In this episode, our hosts are joined by Dr Phil Smiraldo again for his third visit to BiocompCHATibility – he’s an honorary host for sure. Our experts discuss equivalency in biocompatibility with Phil. They talked about how equivalency can range from simple to complex and how a predicate does not always equal equivalency.

“The world of equivalency runs the spectrum from incredibly simple to probably way too complex” Don Pohl

“when we do these types of extractions on, we'll say prior devices and change to device, we're going to have variability within our experiments.” Phil Smiraldo

“You know whether you call it an equivalency assessment or change control assessment. Whatever you want to call it, I mean (10993) part one tells us if there's a change, you have to evaluate it.” Don Pohl

“I guess Long story short, you could theoretically go through this whole exercise and end up with the two devices are equivalent from a systemic toxicity perspective and that's it.” Phil Smiraldo

Discussion points include:

• highlighted the importance of confirming identicalmaterials of construction, device categorization, and the IFU to ensure that the device remains equivalent.
• the level of detail required to prove equivalence
• the importance of being careful and very mindful of the standards