确保医疗器械的有效性和安全性:监管方法的跨国比较。

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2014-01-01
Daniel B Kramer, Yongtian T Tan, Chiaki Sato, Aron S Kesselheim
{"title":"确保医疗器械的有效性和安全性:监管方法的跨国比较。","authors":"Daniel B Kramer,&nbsp;Yongtian T Tan,&nbsp;Chiaki Sato,&nbsp;Aron S Kesselheim","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>Regulatory bodies weighing market approval for novel medical devices must balance the benefits and potential hazards carefully. We performed a legal and policy review of appraoches in the US, EU, Japan, and China to device regulation with a focus on postmarket surveillance. These markets share broad features such as a heavy reliance on passive adverse event collection, reflected by growing enthusiasm for more active and dynamic mechanisms such as unique device identification. More immediately, US and EU systems might benefit from scheduled, compulsory, and consequential re-examination of select devices, as is done in Japan and China, in order to strengthen post-market protection of patients and bolster public health.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":null,"pages":null},"PeriodicalIF":0.3000,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4091615/pdf/nihms594462.pdf","citationCount":"0","resultStr":"{\"title\":\"Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation.\",\"authors\":\"Daniel B Kramer,&nbsp;Yongtian T Tan,&nbsp;Chiaki Sato,&nbsp;Aron S Kesselheim\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Regulatory bodies weighing market approval for novel medical devices must balance the benefits and potential hazards carefully. We performed a legal and policy review of appraoches in the US, EU, Japan, and China to device regulation with a focus on postmarket surveillance. These markets share broad features such as a heavy reliance on passive adverse event collection, reflected by growing enthusiasm for more active and dynamic mechanisms such as unique device identification. More immediately, US and EU systems might benefit from scheduled, compulsory, and consequential re-examination of select devices, as is done in Japan and China, in order to strengthen post-market protection of patients and bolster public health.</p>\",\"PeriodicalId\":12282,\"journal\":{\"name\":\"Food and drug law journal\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.3000,\"publicationDate\":\"2014-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4091615/pdf/nihms594462.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Food and drug law journal\",\"FirstCategoryId\":\"97\",\"ListUrlMain\":\"\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"FOOD SCIENCE & TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Food and drug law journal","FirstCategoryId":"97","ListUrlMain":"","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"FOOD SCIENCE & TECHNOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

监管机构在权衡新型医疗器械的市场批准时,必须仔细平衡其益处和潜在危害。我们对美国、欧盟、日本和中国的设备监管方法进行了法律和政策审查,重点是上市后监管。这些市场具有广泛的特点,如严重依赖被动不良事件收集,反映在对更主动和动态机制(如唯一设备标识)的日益增长的热情。更直接的是,美国和欧盟系统可能会受益于对选定器械的定期、强制性和相应的重新检查,就像日本和中国所做的那样,以加强对患者的上市后保护并促进公共卫生。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation.

Regulatory bodies weighing market approval for novel medical devices must balance the benefits and potential hazards carefully. We performed a legal and policy review of appraoches in the US, EU, Japan, and China to device regulation with a focus on postmarket surveillance. These markets share broad features such as a heavy reliance on passive adverse event collection, reflected by growing enthusiasm for more active and dynamic mechanisms such as unique device identification. More immediately, US and EU systems might benefit from scheduled, compulsory, and consequential re-examination of select devices, as is done in Japan and China, in order to strengthen post-market protection of patients and bolster public health.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
期刊介绍: The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
期刊最新文献
Life, Liberty, [and the Pursuit of Happiness]: Medical Marijuana Regulation in Historical Context Implementing a Public Health Perspective in FDA Drug Regulation Commemorating the 40th Anniversary of the 1976 Medical Device Amendments. FDA-Required Tobacco Product Inserts & Onserts–and the First Amendment. Proposed Industry Best Practices in Development and Marketing of Medical Foods for the Management of Chronic Conditions and Diseases while Awaiting Regulation.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1