[Challenges and Prospects of Medical Device Containing Adaptive Algorithms to Supervision]

Kai Hu; Hui Yang; Chao Zheng; Wen Wang; Lin-Rong Ma

doi:10.3969/j.issn.1671-7104.2022.03.015

[Challenges and Prospects of Medical Device Containing Adaptive Algorithms to Supervision]

Zhongguo Yi Liao Qi Xie Za Zhi. 2022 May 30;46(3):307-311. doi: 10.3969/j.issn.1671-7104.2022.03.015.

[Article in Chinese]

Authors

Kai Hu¹, Hui Yang¹, Chao Zheng¹, Wen Wang¹, Lin-Rong Ma²

Affiliations

¹ Zhejiang Center for Medical Device Evaluation (Zhejiang Center for Medical Device Adverse Events Monitoring), Hangzhou, 310009.
² Zhejiang Center for Drug Inspection, Hangzhou, 310000.

PMID: 35678442
DOI: 10.3969/j.issn.1671-7104.2022.03.015

Abstract

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.

Keywords: adaptive algorithms; medical device; supervision.

MeSH terms

Algorithms*
Artificial Intelligence*