Working With the Food and Drug Administration's Center for Devices to Advance Regulatory Science and Medical Device Innovation

Malinauskas Richard A.; Saha Anindita; Sheldon Murray I.

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Working With the Food and Drug Administration's Center for Devices to Advance Regulatory Science and Medical Device Innovation

机译：与食品和药物管理局的设备一起使用，以推进监管科学和医疗器械创新

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来源
《Artificial Organs》 |2015年第4期|共7页
作者
Malinauskas Richard A.; Saha Anindita; Sheldon Murray I.;
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作者单位

US FDA Off Sci &

Engn Labs Silver Spring MD 20993 USA;

US FDA Ctr Devices &

Radiol Hlth Silver Spring MD 20993 USA;

US FDA Ctr Devices &

Radiol Hlth Silver Spring MD 20993 USA;

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原文格式 PDF
正文语种 eng
中图分类器官移植术;
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1. Working With the Food and Drug Administration's Center for Devices to Advance Regulatory Science and Medical Device Innovation [J] . Malinauskas Richard A., Saha Anindita, Sheldon Murray I. Artificial Organs . 2015,第4期

机译：与美国食品药品监督管理局设备中心合作，促进法规科学和医疗设备创新
2. Working With the Food and Drug Administration's Center for Devices to Advance Regulatory Science and Medical Device Innovation [J] . Malinauskas Richard A., Saha Anindita, Sheldon Murray I. Artificial Organs . 2015,第4期

机译：与食品和药物管理局的设备一起使用，以推进监管科学和医疗器械创新
3. Advancing Regulatory Science to Bring Novel Medical Devices for Use in Emergency Care to Market: The Role of the Food and Drug Administration [J] . Scully Christopher G., Forrest Shawn, Galeotti Loriano, Annals of Emergency Medicine: Journal of the American College of Emergency Physicians and the University Association for Emergency Medicine . 2015,第4期

机译：推进监管科学，将用于急救的新型医疗设备推向市场：食品药品监督管理局的作用
4. CARDIOVASCULAR MEDICAL DEVICES: REGULATORY SCIENCE RESEARCH OVERVIEW IN THE OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL) AT THE FOOD AND DRUG ADMINISTRATION (FDA) [C] . Kenneth Aycock, Ksenia Blinova, Maura Casciola, Design of Medical Devices Conference . 2021

机译：心血管医疗器械：监管科学研究概述在食品和药物管理局（FDA）的科学与工程实验室（OSEL）办公室
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. Advancing Public Health Using Regulatory Science to Enhance Development and Regulation of Medical Products: Food and Drug Administration Research at the Center for Biologics Evaluation and Research [O] . Marc Kusinitz, Emily Braunstein, Carolyn A. Wilson 2017

机译：使用监管科学促进公共卫生以增强医疗产品的开发和监管：生物制剂评估和研究中心的食品和药物管理局研究
7. Advancing Public Health Using Regulatory Science to Enhance Development and Regulation of Medical Products: Food and Drug Administration Research at the Center for Biologics Evaluation and Research [O] . Marc Kusinitz, Emily Braunstein, Carolyn A. Wilson 2017

机译：利用监管科学促进公共卫生加强医疗产品的开发和监管：生物制品评估和研究中心的食品和药物管理研究
8. Contains Nonbinding Recommendations: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Guidance for Industry and Food and Drug Administration Staff. [R] . 2015

机译：包含非约束性建议：医疗设备数据系统，医学图像存储设备和医学图像通信设备工业和食品和药物管理人员指南。

Working With the Food and Drug Administration's Center for Devices to Advance Regulatory Science and Medical Device Innovation

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