首页> 外文OA文献 >Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017

【2h】

Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017

机译：经历过美国食品和药物管理局的医疗设备中召回的风险510（k）清关和预先批准，2008-2017

代理获取

本网站仅为用户提供外文OA文献查询和代理获取服务，本网站没有原文。下单后我们将采用程序或人工为您竭诚获取高质量的原文，但由于OA文献来源多样且变更频繁，仍可能出现获取不到、文献不完整或与标题不符等情况，如果获取不到我们将提供退款服务。请知悉。

页面导航

著录项
引文网络
相似文献
相关主题

著录项

作者
Jonathan R. Dubin; Stephen D. Simon; Kirsten Norrell; Jacob Perera; Jacob Gowen; Akin Cil;
展开▼
作者单位

展开▼
年度 2021
总页数
原文格式 PDF
正文语种
中图分类

相似文献

外文文献
中文文献
专利

1. Comparison of Priority vs Standard US Food and Drug Administration Premarket Approval Review for High-Risk Medical Devices [J] . Ong Caroline, Ly Vy K., Redberg Rita F. JAMA internal medicine . 2020,第5期

机译：优先权与标准美国食品和药物管理局对高风险医疗器械的预售审批审查的比较
2. Analysis of Benefit-risk Balance in Decision-making of the Food and Drug Administration for Premarket Approval of Therapeutic Medical Devices [J] . Yoshihiro MURAGAKI, Miyuki UEMATSU, Hiroshi ISEKI, Advanced Biomedical Engineering . 2013,第2期

机译：食品药品监督管理局治疗性医疗器械上市前批准决策中的利益风险平衡分析
3. Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices, 2000-2014 [J] . Rathi Vinay K., Wang Bo, Ross Joseph S., Otolaryngology--head and neck surgery: official journal of American Academy of Otolaryngology-Head and Neck Surgery . 2017,第2期

机译：支持美国食品和药物管理局的临床证据预先批准高危耳鼻喉科设备，2000-2014
4. Medical Device Approval Process in China since the Introduction of the China Food and Drug Administration [C] . Tobias Lueddemann, Diqing Chang, Sadik Sahin, IEEE Symposium on Product Compliance Engineering . 2016

机译：中国食品和药物管理局引进以来中国医疗器械批准过程
5. Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving US Food and Drug Administration Premarket Approval in 2010 and 2011. [D] . Rathi, Vinay Kumar. 2016

机译：在2010年和2011年获得美国食品药品监督管理局上市前批准的高风险治疗性医疗器械整个产品生命周期中进行的临床研究。
6. United States Food and Drug Administration’s 510(k) Pathway: Drawing Implications from the Approvals of Brachytherapy Devices [O] . Sophie Wang, Albert Manudhane, Harib H Ezaldein, -1

机译：美国食品药品监督管理局（FDA）的510（k）途径：近距离放射治疗设备的批准产生了启示
7. United States Food and Drug Administration’s 510(k) Pathway: Drawing Implications from the Approvals of Brachytherapy Devices [O] . Sophie Wang, Albert Manudhane, Harib H Ezaldein, 2019

机译：美国食品和药物管理局的510（k）途径：绘制近距离放射治疗设备的认证的影响
8. Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet MedicalNeed for Life Threatening or Irreversibly Debilitating Diseases or Conditions: Guidance for Industry and Food and Drug Administration Staff. [R] . 2015

机译：快速进入上市前批准和De Novo医疗器械用于未满足医疗需要的生命威胁或不可逆转的衰弱疾病或条件：工业和食品药品管理局工作人员指南。

Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017

著录项

引文网络

相似文献

相关主题

期刊订阅