从Scanadu的“Scout”中获得批准:众筹时代医疗器械监管的经验教训。

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY
Food and drug law journal Pub Date : 2015-01-01
Colleen Smith
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引用次数: 0

摘要

互联网众筹是一种越来越受欢迎的新型融资方式,用于开发产品和企业。最近,它与美国食品和药物管理局(FDA)对医疗器械的监管发生了冲突。本文探讨了当公司在获得FDA批准之前通过众筹活动预售医疗设备时出现的问题。由于互联网众筹的使用只有几年的时间,学术上关于它的文章很少,特别是关于它与FDA法规的互动。人们对众筹的兴趣日益浓厚,再加上美国医疗器械行业投资的低迷,使得这一突出问题已经成熟,需要FDA进行审查。本文以医疗器械公司Scanadu在2013年开展的众筹活动为起点,为开发其家用诊断设备“Scout”筹集资金。由于开发一种设备并获得FDA批准的成本极高,医疗设备公司应该能够利用众筹来筹集必要的资金。然而,由于医疗设备可能带来的危险,FDA需要审查允许公司众筹医疗设备所带来的风险,并应发布指导意见,帮助公司遵守FDA的规定,同时仍允许他们利用众筹的好处。本指南应确保对消费者安全的持续承诺,这是FDA法规的核心。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu's "Scout".

Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration's (FDA's) regulation of medical devices. This Article examines the issues that arise when companies pre-sell medical devices via crowdfunding campaigns before gaining FDA approval of the devices. Because Internet crowdfunding has only been in use for a few years, little has been written about it academically, particularly about its interaction with FDA regulations. The rising interest in crowdfunding, coupled with the downturn in investment in the American medical device industry, make this a salient issue that is ripe for FDA review. This Article uses the crowdfunding campaign Scanadu, a medical device company, conducted in 2013 to raise money to develop its in-home diagnostic device, the "Scout," as a starting point for this analysis. Because it is extremely costly to develop a device and obtain FDA approval, medical device companies should be able to utilize crowdfunding to raise the necessary capital. However, because of the possible dangers medical devices pose, FDA needs to review the risks created by allowing companies to crowdfund medical devices and should issue guidance to help companies comply with FDA regulations while still allowing them to take advantage of the benefits of crowdfunding. This guidance should ensure the continued commitment to consumer safety that is at the core of FDA regulation.

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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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