Determination of Production Equivalence for V&V and Pivotal Clinical Trials

[EvRi1]

Hello,

Can anyone provide guidance on how to determine and document production equivalence prior to V&V. We are approaching our design freeze with a prototype ME assembly. This assembly uses small scale materials/methods (casting) to keep costs low until preliminary clinical trials and pre-testing have de-risked the device. Eventually we will proceed into a production run with injection molded parts but ideally we would start the pivotal clinical trials and V&V with the prototype before putting the money into molds. The injection molded design will be equivalent in form and function to the prototype but it will use different materials (with better mechanical specifications than the cast per TDS).

This seems like a reasonable plan when referencing the flow charts in FDA's guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device, however it will likely take significant documentation and justification. My main concern is that we would get to the other side of clinicals/conformance testing to international standards and all the results would be invalidated becuase of the material change. I fully expect we would be required to repeat testing that would be effected by the material change but I am hoping we can isolate those tests instead of repeating clinicals or all of 60601 general/collateral/particular.

Please let me know your thoughts/experiences with production equivalence justifications.
Thanks!!

 

[yodon]

It's going to be specific to a test. How would you answer "why are the test results valid even though I changed (in your example) materials"? Obviously, you couldn't claim production equivalence for, say, biocompatibility testing. You wouldn't be able to claim production equivalence for, say, drop tests (if that's applicable) since you say the materials are different. If you're testing something that the materials have no effect on, then you should be able to craft a justification. I don't know how much of 60601-1 testing you'd want to do with different materials. I would think a test lab will be pretty particular when it comes to things like drop testing, ball impact, etc. Most test labs I've worked with have been amenable to discussing it with you and identifying what tests can be done -v- what would have to be re-done.

 

[EvRi1]

Yeah that makes sense to me. I will open a discussion with my test lab. I feel like this must be somewhat common as it is hard for me to imagine companies still in the R&D phase fronting the cost of injection molds without having critical clinical data and/or safety certs in order. We are a small startup company who have been lucky enough to get through a couple preliminary clinical trials but we will struggle to put down the money required for everything (molds, certs, clinicals and regulatory submission) all at once which is why it would be ideal to break it out like I have described above.

 

[EvRi1]

My lab replied with a similar sentiment. They will repeat all testing that is effected by the material change and we can justify the testing that is not necessary. Therefore we would be looking at redoing all mechanical, marking durability, fluid ingress testing. However, we can likely justify validity of electrical and thermal testing if the parameters of the materials are close enough. The lab would then update the report and provide re-certification. Ultimately it is increased work, time and money but doesn't seem overly complicated or expensive.