n this episode of NAMSA’s BiocompCHATibility podcast, we welcome back Dr. Phil Smiraldo (Principal Toxicologist, NAMSA) for his third appearance as an honorary host. The discussion centers on the complexities of equivalency in biocompatibility, examining how equivalency can range from simple to complex and how a predicate device does not always equal equivalency.

Listen in as we explore these topics with Dr. Smiraldo and gain insights into the intricate world of biocompatibility and the challenges faced when trying to establish equivalence between medical devices.

“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 that are equivalent from a systemic toxicity perspective and that's it.” – Phil Smiraldo

Key Discussion Points

• Importance of confirming identical materials of construction, device categorization, and the IFU to ensure that the device remains equivalent
• The detailed process required to establish proof of equivalence
• The critical role of adhering to standards in biocompatibility assessments