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Dear all, we are frequently in discussion regarding the transferability of biocompatibility testing. For example we have a tubing System 1 consisting of 4 different components (biocompatibility for this system is available)and another tubing system 2 consisting of 6 different components (different to those from the first tubing system - biocompatibility for this System is available). Now we are developing a third tubing system consisting of a mixture of the components of tubing System 1 and 2 (no new components).
Manufacturing conditions are similar to sytem 1 and 2.
Is it necessary to perform all biocompatibility test for this new tubing system? Or is it possible to perform only the in vitro testings and refer to the in vivo testings of tubing system 1 and 2).
Thank you very much.
Medical Device Committee
The medical device committee have considered your question and have the following response:
The extent of the biocompatibility testing which will be required should be determined by conducting a thorough risk analysis for the new application. Consider in detail the new application of the materials, will they be in contact with the same tissues or fluids as in the previous applications, in which case some of the previous data may be relevant, or will the materials be in contact with different tissues or fluids. A sound scientific justification for the risk determination is required. It would also be important to consider any cumulative impact of the combination.
It should also be noted that manufacturers have a responsibility under RRR to limit in vivo testing to only that which is absolutely required.