Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United States.
10.12455/j.issn.1671-7104.240522
- Author:
Xiaofang GU
1
;
Yuanyuan HOU
1
;
Kai LIN
1
;
Juenan PAN
2
Author Information
1. Hainan Service Center for Drug and Medical Device Evaluation, Haikou,
2. Hainan Medical Products Administration, Haikou,
- Publication Type:Journal Article
- Keywords:
real-world data;
real-world evidence;
real-world study;
regulatory decisions
- MeSH:
United States;
United States Food and Drug Administration;
Equipment and Supplies;
Device Approval;
China
- From:
Chinese Journal of Medical Instrumentation
2025;49(4):460-465
- CountryChina
- Language:Chinese
-
Abstract:
In recent years, with the development of big data application technology, the real-world data and the corresponding generated real-world evidence have attracted the attention of healthcare regulatory authorities around the world. Regulators recognize that real-world research with specific purposes using real-world data can provide important evidence for regulatory decisions. A total of 90 instances of publicly released on the application of real-world evidence to support regulatory decisions of U. S. Food and Drug Administration are explored, and the positioning and value of real-world evidence in U. S. Food and Drug Administration regulatory decisions are summarized and analyzed, providing references for the use of real-world data and real-world evidence to promote medical devices whole cycle regulation in China.
