Against the backdrop of rapid advancements in medical technology,the reliance on traditional randomized controlled trials(RCTs)for the regulatory approval of medical devices has become increasingly inadequate.The inherent complexity and variability of medical devices often pose methodological and ethical challenges to clinical trials,substantially hindering the applicability and effectiveness of RCTs.This paper advocates for a paradigm shift in medical device regulatory decision-making by embracing a wider variety of valid scientific evidence,including real-world data and real-world evidence,aligning with the adaptive regulatory guidelines of the U.S.Food and Drug Administration.This approach aims to strike a balance between fostering innovation and ensuring the safety and effectiveness of medical devices,proposing a more flexible and inclusive regulatory framework tailored to the unique characteristics of medical devices.
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