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.