Subjects: Medicine, Pharmacy >> Clinical Medicine Subjects: Management Science >> Other Disciplines of Management Science submitted time 2023-12-09
Abstract: We collected summaries/review reports of fractional flow reserve (FFR) and related products approved in the US and China, and together with relevant clinical literature and clinical guidelines, analyzed the registration administration strategy for such medical device software, especially clinical data requirement. In general, the US is more flexible regarding clinical data request, which was not even submitted for early FFR products when clinical benefits were not claimed. Clinical data was submitted for the following products during equivalence demonstration; however, mainly being diagnostic consistence comparison study with predicate device instead of strict prospective clinical trials. When the clinical benefits were confirmed in clinical trials with clinical outcome as the primary endpoint, this claim was added to product indications. Besides, the practice of efficiently leveraging social resources via data sharing in the US is worth learning.
Peer Review Status:Awaiting Review