Good Afternoon,
Can anyone provide some guidance regarding the baseline requirements for determining/documenting production equivalence of medical devices to be used in validation testing per 21 CFR 820.30? How would one go about ensuring / documenting production equivalence for devices produced prior to process validation?
Any suggestions or recommendations would be greatly appreciated!!!
Thank you,
Amy
Hi,
It's a bit difficult to give a general answer; if you say what the device is and what types of processes are used for manufacturing, more focused guidance may be provided.
In general, if the same kind of process is utilized as is going to be in full-scale production, and perhaps even the same equipment (or most of it), then there may be a case for equivalence. For instance, for injection molding you are expected to use the multi-cavity production tool rather than a single cavity prototype tool, and run it on a production machine rather than in the R&D shop. Machining the part to similar specifications would not count as equivalent, at least not without a thorough justification. It's not always a clear cut though, and may depend on the specific constraint set. I'm not sure how acceptive the FDA is to arguments such as "it would cost too much and take too long to be commercially viable".
Documentation would involve detailed justifications wherever deviations are made from the full-scale process / equipment (why you think the preliminary process is still a good representation of the full-scale, in terms of providing evidence that the design meets user needs), and could go into the validation plan / report (in the DHF).
Cheers,
Ronen.