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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.

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。

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作者
Rathi, Vinay Kumar.;
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作者单位

Yale University.;

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授予单位 Yale University.;
学科 Medicine.
学位 M.D.
年度 2016
页码 53 p.
总页数 53
原文格式 PDF
正文语种 eng
中图分类
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专利

1. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011 [J] . Rathi Vinay K., Krumholz Harlan M., Masoudi Frederick A., JAMA: the Journal of the American Medical Association . 2015,第6期

机译：在2010年和2011年获得FDA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的特征
2. 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
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. A review of the Federal Drug Administration's policy statement on new plant varieties and approval procedures for genetically modified food products. [D] . DeVoe, Meghan Elizabeth. 2014

机译：审查了联邦药品管理局关于转基因食品新植物品种和批准程序的政策声明。
6. Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration [O] . Ellen Pinnow, Naomi Herz, Nilsa Loyo-Berrios, -1

机译：食品药品监督管理局要求的医疗器械批准后研究中的妇女注册和监测
7. Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017 [O] . Jonathan R. Dubin, Stephen D. Simon, Kirsten Norrell, 2021

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
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。

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.

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