Abstract
We have developed in vitro test methodologies modeling in vivo practical-use situations, to quantitatively assess safety and effectiveness of innovative medical devices. We believe that expediting development of these in vitro methodology not only reinforce preclinical evaluation and enhance timely access to innovative medical devices for patients but also reduce potential risk when used in real-world clinical practice, because controlled clinical trials have certain limitation in fully demonstrating benefit and risk. With the grant from Ministry of Health, Labour and Welfare intended for "Promotional Project for Practical Application of Innovative Pharmaceutical, Medical Device, and Tissue Engineering Products", we have developed drafts on in vitro test guideline for "Durability testing methods for coronary artery stent", "Durability testing methods for vascular stent intended for Superficial femoral - Popliteal artery", and "Method for in vitro thrombogenicity testing for inflow cannula of left ventricular assist system". Further 5 guideline drafts are under preparation. Here, we introduce impacts of in vitro test methods modeling in vivo intended-use situations on expediting availability of new medical devices and timely assessment and management of risk.
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