When Calculating The Sample Size Of Diagnostic Devices In Clinical Trials, Can We Refer To “Guidelines For Design Of Clinical Trials Of Medical Devices”?

Yes, the scope of the “Guidelines for Design of Clinical Trials of Medical Devices” is clearly state that this guideline applies to medical devices that have been finalized in product composition, design, and performance, including therapeutic products, diagnostic products, excluding in vitro diagnostic reagents (IVDs). Therefore, diagnostic devices can refer to the relevant requirements in this guideline when calculating the sample size for clinical trial design.