I hope I didn't confuse anyone with the link to the Guidance Document for when to submit a new 510(k). My point was that if you want to be very cautious, you may wish to review that document and confirm that no new 510(k) is needed.
I understood your use in including the document. I still feel like the statement I included implies that a risk assessment could conclude that no new biocompatibility testing would be needed for a 1:1 supplier change, and I haven't seen anything in 10993 or its FDA guidance that directly says that a change in supplier = new biocomp testing. For example, from the FDA guidance on 10993:
"Another common change that might impact biocompatibility is a change in resin supplier. For example, if the new resin supplier does not remove all processing solvents (some of which may be known toxic compounds, such as formaldehyde), the final manufactured device could cause unexpected toxicities (e.g., cytotoxicity, irritation, sensitization, genotoxicity) that were not seen with devices manufactured from the original resin."
Key word being "might". If both suppliers have a USP Class VI cert, wouldn't that imply that any toxic compounds left over after manufacture are equivalent and would not be expected to cause a change in toxicities? Also, couldn't you verify through a master file that there are not any differences in processing solvents that would cause new concerns for biocompatiblity?
Thanks again for both your help on this. I know that generally it has been standard to re-do biocomp testing, but I haven't seen a direct link to anything that says it is necessary even if there is a valid risk assessment that states there are no new questions of toxicities. Working with startups, re-doing biocompatibility testing can be 100% cost prohibitive to a simple 1:1 supply switch so it is quite frustrating that it is expected.