Understanding and Thinking on America Clinical Evaluation of Medical Devices.
- Author:
Fuqiang YUAN
;
Peng YUAN
;
Gang DENG
- Publication Type:Journal Article
- MeSH:
Equipment and Supplies;
standards;
Risk Assessment;
United States;
United States Food and Drug Administration
- From:
Chinese Journal of Medical Instrumentation
2015;39(5):372-387
- 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.
