For Active Medical Devices With Software, How To Consider The Influence Of Software Difference Using Comparison With Predicate Medical Device In Clinical Evaluation?

Software difference may cause difference in product performances, clinical functions and core algorithms. According to the “‘Guidance for clinical evaluation of medical devices”, this difference shall be considered in the comparison.

During the comparison, the administrative counterparts shall describe all the difference related to the software in detail and analyze the influence on the safety and effectiveness of the products. If necessary, administrative counterparts shall provide the clinical/non-clinical data of the submitting product itself to prove that the difference has no adverse impact on the safety and effectiveness.