Understanding and Thinking on America Clinical Evaluation of Medical Devices
10.3969/j.issn.1671-7104.2015.05.020
- VernacularTitle:美国医疗器械临床评价详解与思考
- Author:
Fuqiang YUAN
1
;
Peng YUAN
;
Gang DENG
Author Information
1. 中国食品药品检定研究院
- Keywords:
medical device product;
risk classification;
clinical evaluation;
clinical data;
clinical trial
- From:
Chinese Journal of Medical Instrumentation
2015;(5):372-375,387
- CountryChina
- Language:Chinese
-
Abstract:
This paper introduces the risk classification and listing way of medical devices in the United States, and according to the contents in various situations, FDA provides the requirements for clinical evaluation. At the same time, through the comparative study on the similarities and differences between USA and our country of the clinical evaluation, the paper puts forward some suggestions.
