Challenges and Prospects of Medical Device Containing Adaptive Algorithms to Supervision.
10.3969/j.issn.1671-7104.2022.03.015
- Author:
Kai HU
1
;
Hui YANG
1
;
Chao ZHENG
1
;
Wen WANG
1
;
Lin-Rong MA
2
Author Information
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.
- Publication Type:Journal Article
- Keywords:
adaptive algorithms;
medical device;
supervision
- MeSH:
Algorithms;
Artificial Intelligence
- From:
Chinese Journal of Medical Instrumentation
2022;46(3):307-311
- CountryChina
- Language:Chinese
-
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.
