The critical path from pump to pancreas: the impact of FDA regulation on the development of a closed-loop diabetes management system.

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY
Food and drug law journal Pub Date : 2013-01-01
Rachel M Sanchez
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引用次数: 0

Abstract

Breakthrough medical tools and technologies are rapidly becoming available in countries across the world, but cannot be purchased in the United States, where these innovative products still await FDA approval. The artificial pancreas is a prime example of such medical technologies, as one of these device systems has been available in over 40 countries outside of the United States for more than 3 years. The term "artificial pancreas" refers to any one of a group of closed-loop device systems designed to protect type 1 diabetics against dangerous diabetes episodes, while also reducing the risk of diabetes-related complications by enabling tighter glycemic control. The following paper will provide an overview of diabetes, a brief history of diabetes management, the technological challenges of creating a fully functional closed-loop diabetes management system, and the role of FDA in the development of the artificial pancreas.

从泵到胰腺的关键路径:FDA法规对糖尿病闭环管理系统发展的影响。
突破性的医疗工具和技术正在世界各国迅速普及,但在美国却无法购买,这些创新产品仍在等待FDA的批准。人工胰腺是这种医疗技术的一个主要例子,因为这些设备系统之一已经在美国以外的40多个国家使用了3年多。“人工胰腺”一词指的是一组闭环装置系统中的任何一个,旨在保护1型糖尿病患者免受危险的糖尿病发作,同时通过加强血糖控制来降低糖尿病相关并发症的风险。下面的文章将提供糖尿病的概述,糖尿病管理的简史,创建全功能闭环糖尿病管理系统的技术挑战,以及FDA在人工胰腺发展中的作用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
期刊介绍: The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
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