The US Food and Drug Administration's New Regulatory Toolkit to Bring Medical Device Innovation Back to the United States

Eydelman Malvina B.; Tieuvi Nguyen; Green J. Angelo

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The US Food and Drug Administration's New Regulatory Toolkit to Bring Medical Device Innovation Back to the United States

机译：美国食品药品监督管理局的新法规工具包将医疗器械创新带回美国

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《JAMA ophthalmology》 |2016年第4期|共2页
作者
Eydelman Malvina B.; Tieuvi Nguyen; Green J. Angelo;
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正文语种 eng
中图分类眼科学;
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1. The US Food and Drug Administration's New Regulatory Toolkit to Bring Medical Device Innovation Back to the United States [J] . Eydelman Malvina B., Tieuvi Nguyen, Green J. Angelo JAMA ophthalmology . 2016,第4期

机译：美国食品药品监督管理局的新法规工具包将医疗器械创新带回美国
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
3. Working With the Food and Drug Administration's Center for Devices to Advance Regulatory Science and Medical Device Innovation (vol 39, pg 293, 2015) [J] . Malinauskas R. A., Saha A., Sheldon M. I Artificial Organs . 2015,第6期

机译：与美国食品药品监督管理局设备中心合作，促进监管科学和医疗设备创新（第39卷，第293页，2015年）
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. Regulatory Considerations for Physiological Closed-Loop Controlled Medical Devices Used for Automated Critical Care: Food and Drug Administration Workshop Discussion Topics [O] . Bahram Parvinian, Christopher Scully, Hanniebey Wiyor, -1

机译：用于自动重症监护的生理闭环控制医疗设备的法规注意事项：食品和药物管理局讲习班的讨论主题
7. Food and Drug Administration Starts Treating Mobile Medical Apps as Medical Devices [O] . Thomas Kampfrath 2014

机译：食品和药物管理局开始将移动医疗应用视为医疗设备
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。

The US Food and Drug Administration's New Regulatory Toolkit to Bring Medical Device Innovation Back to the United States

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