Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United States
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 u...
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| Main Authors: | , , , |
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| Format: | Article |
| Language: | zho |
| Published: |
Editorial Office of Chinese Journal of Medical Instrumentation
2025-07-01
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| Series: | Zhongguo yiliao qixie zazhi |
| Subjects: | |
| Online Access: | https://zgylqxzz.xml-journal.net/article/doi/10.12455/j.issn.1671-7104.240522 |
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| Summary: | 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. |
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| ISSN: | 1671-7104 |