What Factors May Affect Biocompatibility Risk When Using Biological Test Data From Similar Devices For Biological Evaluation?

1. The main factors affecting biocompatibility risk include the chemical composition of the product materials (including the proportion of each component), the physical structure of the product, surface characteristics, production processes, sterilization methods, raw material suppliers, and technical specifications. For liquid or moist-preserved products, the internal packaging materials must also be considered.
2. If there are discrepancies between the similar product and the device under application regarding the factors listed above, sufficient justification and evidence must be provided to support the applicability of the submitted test report to the device under application. If necessary, supplementary biological evaluation data should be provided, such as extractable analysis and toxicological risk assessment data, and supplementary biological test items as required.