This is the audio from RQM+ Live! #52, recorded 7 April, 2022.

During our previous show on this topic we were flooded with questions from viewers (which we love!) and couldn't answer them all, so we're back for a sequel.

Generating evidence of biocompatibility continues to be a significant challenge to regulatory submission success and product-to-market timelines. And global requirements and interpretations continue to evolve, further increasing the challenge.

Rollover questions we'll kick the discussion off with:

The panel of subject matter experts, including former FDA CDRH and BSI leaders:

Questions:

2:28 -- Have you had any unique or unexpected feedback from notified bodies or the FDA? Have you seen any misinterpretations?

9:26 -- Does the FDA influx of new staff factor into the micromanaged questioning and more rigorous approach?

13:20 -- Are we seeing any delays because of laboratories being backed up?

16:50 -- Are there trends from the FDA on adopting biocompatibility testing? Is there an uptake for special 510(k) submissions?

18:02 -- Has anyone had FDA pushback on LCMS ionization mode justification ACPI vs. ESI? (more context added throughout question)

23:29 -- Has anyone had any experience with questions on biocompatibility over the lifetime? If the device is reusable, should the cleaning agents be incorporated in the testing as well?

26:57 -- What testing do you recommend to confirm that a suspected cleaning operation doesn’t leave the part with significant contamination; e.g., cleaning off mold release or stainless-steel solder flux?

30:10 -- How are we advising our clients with legacy devices and their approach?

32:44 -- How do you use exemptions for intact skin devices made of common materials (U.S.)?

36:58 -- Differences between physical and/or chemical information vs. chemical characterization... what are your thoughts?

39:40 -- What do you do if you have a large number of unknowns in chemical characterization?

41:20 -- What about devices that are compatible with chemical characterization?

43:30 -- Do the manufacturers need to provide any evidence for their CrCo device whether the cancer and death cases reported in their PMS are not related to Cobalt content in the device?