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We're a young start-up medical device company and our products are bTCP bone graft, bTCP-Hap bone graft and bTCP-calcium sulfate injection type bone graft.
We are now planning the biocompatibility test for 510(k) submission.
According to my regulatory and 10993 knowledge, three final products should conduct their own 10993 test separately.
However, RD department insist that since they can prove these products do not have any interacted effect, so three final products can be extract in one extract solution (used the extraction of bTCP to extract bTCP-Hap and then extract bTCP-calcium sulfate, so it would not have any dilute problem) and conduct one full biocompatibility test. The cost is only 1/3 compare to the three individual product testing.
I am really confusing,
it's sound quite logistic, although i concerned about the thought of one solution extract three sample would be the same situation for single product extraction (based on those solvent/solution chemistry things), and for me, according to the regulatory, it seems not right.
Any experience?or has anyone been facing this problem too?
please help and thousand thanks!
We are now planning the biocompatibility test for 510(k) submission.
According to my regulatory and 10993 knowledge, three final products should conduct their own 10993 test separately.
However, RD department insist that since they can prove these products do not have any interacted effect, so three final products can be extract in one extract solution (used the extraction of bTCP to extract bTCP-Hap and then extract bTCP-calcium sulfate, so it would not have any dilute problem) and conduct one full biocompatibility test. The cost is only 1/3 compare to the three individual product testing.
I am really confusing,
it's sound quite logistic, although i concerned about the thought of one solution extract three sample would be the same situation for single product extraction (based on those solvent/solution chemistry things), and for me, according to the regulatory, it seems not right.
Any experience?or has anyone been facing this problem too?
please help and thousand thanks!