含自适应算法的医疗器械对监管的挑战与展望

Challenges and Prospects of Medical Device Containing Adaptive Algorithms to Supervision

随着市场的发展和需求的变化,在医疗器械产品中使用自适应算法成为一种可能的发展方向。而自适应算法本身存在的一些不确定性,将会给现有监管模式带来挑战。该文聚焦于美国监管机构在人工智能器械产品监管上的尝试,探讨了现有试点政策在面对含自适应算法产品时可能遇到的难题。以此提出相关建议,期待与业界学者共同探讨。

With the market development and demand change,the use of adaptive algorithms in medical devices has become a possible trend.However,some uncertainties in the adaptive algorithm itself will bring challenges to the existing current supervisory work model.This article focuses on the ademptions of US agencies on artificial intelligence device supervision,and discusses the problems that existing pilot policies may encounter when facing devices with adaptive algorithms.In this way,we will provide relevant suggestions and look forward to discussing with scholars.