Can The Applicant Choose A Typical Model Of Devices To Conduct A Clinical Trial If There Are Multiple Models In One Registry Unit?


2023-04-19

The typical model(s) can be selected to conduct clinical trials. For other models without clinical trials, the identities and differences between other models and typical models should be detailed, and the evidence of clinical safety and effectiveness of the selected typical model products can be extrapolated to all models of products in question.