Concepts in US Food and Drug Administration Regulation of Artificial Intelligence for Medical Imaging

Kohli Ajay; Mahajan Vidur; Seals Kevin; Kohli Ajit; Jha Saurabh

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Concepts in US Food and Drug Administration Regulation of Artificial Intelligence for Medical Imaging

机译：美国食品和药物管理局医学成像人工智能的概念

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OBJECTIVE. Although extensive attention has been focused on the enormous potential of artificial intelligence (AI) technology, a major question remains: how should this fundamentally new technology be regulated? The purpose of this article is to provide an overview of the pathways developed by the U.S. Food and Drug Administration to regulate the incorporation of AI in medical imaging.

机译：客观的。虽然广泛的关注一直专注于人工智能（AI）技术的巨大潜力，但仍有一个主要问题：这是如何监管这一基本新技术的吗？本文的目的是提供美国食品和药物管理局开发的途径概述，以调节AI在医学成像中的掺入。

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《AJR: American Journal of Roentgenology : Including Diagnostic Radiology, Radiation Oncology, Nuclear Medicine, Ultrasonography and Related Basic Sciences》 |2019年第4期|共3页
作者
Kohli Ajay; Mahajan Vidur; Seals Kevin; Kohli Ajit; Jha Saurabh;
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作者单位

Drexel Univ Hahnemann Univ Hosp Dept Radiol Coll Med 230 N Broad St Philadelphia PA 19102 USA;

Ctr Adv Res Imaging Neurosci &

Genom Mahajan Imaging Delhi India;

Univ Calif San Francisco Dept Radiol San Francisco CA USA;

Oklahoma State Univ Coll Osteopath Med Tulsa OK USA;

Univ Penn Hlth Syst Dept Radiol Philadelphia PA USA;

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原文格式 PDF
正文语种 eng
中图分类放射医学;
关键词
artificial intelligence; Food and Drug Administration;

机译：人工智能;食品和药物管理局;

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1. Concepts in US Food and Drug Administration Regulation of Artificial Intelligence for Medical Imaging [J] . Kohli Ajay, Mahajan Vidur, Seals Kevin, AJR: American Journal of Roentgenology : Including Diagnostic Radiology, Radiation Oncology, Nuclear Medicine, Ultrasonography and Related Basic Sciences . 2019,第4期

机译：美国食品和药物管理局医学成像人工智能的概念
2. 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 [J] . Marc Kusinitz, Emily Braunstein, Carolyn A. Wilson Frontiers in Medicine . 2017,第1期

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
3. EDUCATING NURSES ON THE ROLE OF THE FOOD AND DRUG ADMINISTRATION IN THE REGULATION OF MEDICAL DEVICES. [J] . Marin Keith Oncology nursing forum . 2017,第2期

机译：教育护士对食品和药物管理局在医疗器械监管中的作用。
4. Irradiation of Prepackaged Food: Evolution of the U.S. Food and Drug Administration's Regulation of the Packaging Materials [C] . Kristina E. Paquette American Chemical Society . 2004

机译：预包装食品的照射：美国食品和药物管理局的进化的包装材料调节
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. Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective Randomized Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc [O] . Richard T. Holt, Mohammed E. Majd, Jorge E. Isaza, 2007

机译：腰椎间盘置换术与融合术相比的并发症：来自美国食品药品监督管理局的前瞻性随机多中心Charité人工椎间盘调查设备豁免研究的结果
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。

Concepts in US Food and Drug Administration Regulation of Artificial Intelligence for Medical Imaging

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