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Market of First Launch for High-Risk Therapeutic Medical Devices.

作者信息

Kadakia Kushal T, Lalani Christina, Kramer Daniel B, Orui Hibiki, Yeh Robert W

机构信息

Harvard Medical School, Boston, Massachusetts.

Division of Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.

出版信息

JAMA Netw Open. 2024 Dec 2;7(12):e2449298. doi: 10.1001/jamanetworkopen.2024.49298.

DOI:10.1001/jamanetworkopen.2024.49298
PMID:39641932
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11624582/
Abstract
摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f460/11624582/0e2de4eb2fce/jamanetwopen-e2449298-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f460/11624582/0e2de4eb2fce/jamanetwopen-e2449298-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f460/11624582/0e2de4eb2fce/jamanetwopen-e2449298-g001.jpg

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本文引用的文献

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Nat Biotechnol. 2020 Aug;38(8):933-938. doi: 10.1038/s41587-020-0636-7.
2
Comparison of Priority vs Standard US Food and Drug Administration Premarket Approval Review for High-Risk Medical Devices.高风险医疗器械的优先审查与标准美国食品和药物管理局上市前审批的比较。
JAMA Intern Med. 2020 May 1;180(5):801-803. doi: 10.1001/jamainternmed.2020.0297.
3
Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study.
欧盟和美国批准的医疗器械安全问题发生率及试验结果报告的比较：队列研究。
BMJ. 2016 Jun 28;353:i3323. doi: 10.1136/bmj.i3323.