1 回答
Software difference may cause difference in productperformances,clinical functions and core algorithms. Accordingto the“Guidance for clinical evaluation of medical devices”, thisdifference shall be considered in the comparison.During the comparison, the administrative counterpartsshall describe all the difference related to the software in detailand analyze the influence on the safety and effectiveness of theproducts. If necessary, administrative counterparts shall providethe clinical/non-clinical data of the submitting product itself toprove that the difference has no adverse impact on the safety andeffectiveness.
