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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| Format: | Article |
| Language: | zho |
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Editorial Office of Chinese Journal of Medical Instrumentation
2025-07-01
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| Series: | Zhongguo yiliao qixie zazhi |
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| Online Access: | https://zgylqxzz.xml-journal.net/article/doi/10.12455/j.issn.1671-7104.240522 |
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| _version_ | 1849736336564551680 |
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| author | Xiaofang GU Yuanyuan HOU Kai LIN Juenan PAN |
| author_facet | Xiaofang GU Yuanyuan HOU Kai LIN Juenan PAN |
| author_sort | Xiaofang GU |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-c99fbc77ade5420eb8fedd185bfe569e |
| institution | DOAJ |
| issn | 1671-7104 |
| language | zho |
| publishDate | 2025-07-01 |
| publisher | Editorial Office of Chinese Journal of Medical Instrumentation |
| record_format | Article |
| series | Zhongguo yiliao qixie zazhi |
| spelling | doaj-art-c99fbc77ade5420eb8fedd185bfe569e2025-08-20T03:07:19ZzhoEditorial Office of Chinese Journal of Medical InstrumentationZhongguo yiliao qixie zazhi1671-71042025-07-0149446046510.12455/j.issn.1671-7104.2405222024-0522Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United StatesXiaofang GU0Yuanyuan HOU1Kai LIN2Juenan PAN3Hainan Service Center for Drug and Medical Device Evaluation, Haikou, 570216Hainan Service Center for Drug and Medical Device Evaluation, Haikou, 570216Hainan Service Center for Drug and Medical Device Evaluation, Haikou, 570216Hainan Medical Products Administration, Haikou, 570216In 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.https://zgylqxzz.xml-journal.net/article/doi/10.12455/j.issn.1671-7104.240522real-world studyreal-world datareal-world evidenceregulatory decisions |
| spellingShingle | Xiaofang GU Yuanyuan HOU Kai LIN Juenan PAN Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United States Zhongguo yiliao qixie zazhi real-world study real-world data real-world evidence regulatory decisions |
| title | Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United States |
| title_full | Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United States |
| title_fullStr | Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United States |
| title_full_unstemmed | Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United States |
| title_short | Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United States |
| title_sort | research on application of medical device real world evidence in regulatory decisions of the united states |
| topic | real-world study real-world data real-world evidence regulatory decisions |
| url | https://zgylqxzz.xml-journal.net/article/doi/10.12455/j.issn.1671-7104.240522 |
| work_keys_str_mv | AT xiaofanggu researchonapplicationofmedicaldevicerealworldevidenceinregulatorydecisionsoftheunitedstates AT yuanyuanhou researchonapplicationofmedicaldevicerealworldevidenceinregulatorydecisionsoftheunitedstates AT kailin researchonapplicationofmedicaldevicerealworldevidenceinregulatorydecisionsoftheunitedstates AT juenanpan researchonapplicationofmedicaldevicerealworldevidenceinregulatorydecisionsoftheunitedstates |