Whether A Similar Device Can Be Chosen As A Control Product In A Parallel Controlled Clinical Trial?

When conducting parallel controlled clinical trials, if a similar product already on the market cannot be used as a control product for reasonable reasons, product design characteristics, preclinical trial research results, risk and benefit analysis, clinical trial objectives, clinical trial evaluation indicators, and follow-up time may be considered in a comprehensive manner to select similar products that have been recognized for their efficacy and safety, the same scope of application as test equipment, and similar clinical evaluation indicators with test equipment as control products.