{"title":"医疗器械颜色添加剂的灰色。","authors":"Brenda Seidman","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>The United States' medical device color additive regulations are unknown to some, and confusing to many. This article reviews statutory language on color additives in the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended, including the Delaney Clause on carcinogenicity; color additive regulatory language as it relates to medical devices in Title 21 of the Code of Federal Regulations (C.F.R.), Parts 70-82; reports on the Food and Drug Administration's (FDA's) likely current and historical practices in dealing with color additives in medical devices; and speculates on what may have given rise to decades of seemingly ad hoc color additives practices, which may now be difficult to reconstruct and satisfactorily modify. Also addressed is the Center for Devices and Radiological Health's (CDRH's) recent publicly-vetted approach to color additives in Section 7 of its April 2013 draft guidance, Use of International Standard ISO-10993, \"Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,\" which the author concludes is a change in the right direction, but which, at least in its current draft form, is not a fix to the CDRH's color additives dilemma. Lastly, the article suggests what the CDRH might consider in further developing a new approach to color additives. Such an approach would treat color additives as if they were any other potentially toxic group of chemicals, and could be fashioned in such a way that the CDRH could still satisfy the broad aspects of Congressional color additives mandates, and.yet be consistent with ISO 10993. In doing this, the CDRH would need to recommend a more directed use of its Quality System Regulation, 21 C.F.R. 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This article reviews statutory language on color additives in the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended, including the Delaney Clause on carcinogenicity; color additive regulatory language as it relates to medical devices in Title 21 of the Code of Federal Regulations (C.F.R.), Parts 70-82; reports on the Food and Drug Administration's (FDA's) likely current and historical practices in dealing with color additives in medical devices; and speculates on what may have given rise to decades of seemingly ad hoc color additives practices, which may now be difficult to reconstruct and satisfactorily modify. 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引用次数: 0
摘要
美国的医疗器械颜色添加剂法规对一些人来说是未知的,对许多人来说是困惑的。本文回顾了经修订的《联邦食品、药品和化妆品法》(FFDCA)中关于颜色添加剂的法定语言,包括关于致癌性的德莱尼条款;联邦法规第21篇(cfr)第70-82部分中与医疗器械相关的颜色添加剂监管语言;关于美国食品和药物管理局(FDA)在处理医疗器械中颜色添加剂方面可能的当前和历史做法的报告;并推测可能是什么导致了几十年来看似特别的颜色添加剂的做法,现在可能很难重建和令人满意的修改。还讨论了设备和放射健康中心(CDRH)最近在其2013年4月指南草案第7节中对颜色添加剂的公开审查方法,使用国际标准ISO-10993,“医疗器械的生物评价第1部分:评估和测试”,作者认为这是朝着正确方向的改变,但是,至少在其目前的草案形式中,这并不能解决CDRH的颜色添加剂困境。最后,文章提出了CDRH在进一步开发颜色添加剂的新方法时可能考虑的问题。这种方法将把颜色添加剂视为任何其他潜在有毒的化学物质,并且可以以这样一种方式形成,即CDRH仍然可以满足国会颜色添加剂授权的广泛方面,并且。但与ISO 10993一致。在此过程中,CDRH需要建议更直接地使用其质量体系法规,21 cfr Part 820,用于材料和供应商的资格和验证;向国会提出必要的法律变更;或者进行管理上的改变。为了任何方法获得成功,是否一个新的转折在过去的做法,或一个全新的路径前进,FDA必须尽其能力,更好地了解它的过去医疗设备颜色添加剂实践(以及发达的变化在过去的二十年左右),并参与对它如何与利益相关者对话和医疗设备行业应该考虑未上市的颜色添加剂目前在销售设备在美国使用。
The United States' medical device color additive regulations are unknown to some, and confusing to many. This article reviews statutory language on color additives in the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended, including the Delaney Clause on carcinogenicity; color additive regulatory language as it relates to medical devices in Title 21 of the Code of Federal Regulations (C.F.R.), Parts 70-82; reports on the Food and Drug Administration's (FDA's) likely current and historical practices in dealing with color additives in medical devices; and speculates on what may have given rise to decades of seemingly ad hoc color additives practices, which may now be difficult to reconstruct and satisfactorily modify. Also addressed is the Center for Devices and Radiological Health's (CDRH's) recent publicly-vetted approach to color additives in Section 7 of its April 2013 draft guidance, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," which the author concludes is a change in the right direction, but which, at least in its current draft form, is not a fix to the CDRH's color additives dilemma. Lastly, the article suggests what the CDRH might consider in further developing a new approach to color additives. Such an approach would treat color additives as if they were any other potentially toxic group of chemicals, and could be fashioned in such a way that the CDRH could still satisfy the broad aspects of Congressional color additives mandates, and.yet be consistent with ISO 10993. In doing this, the CDRH would need to recommend a more directed use of its Quality System Regulation, 21 C.F.R. Part 820, for material and vendor qualification and validation in general; approach Congress for needed statutory changes; or make administrative changes. In order for any approach to be successful, whether it is a new twist on past practices, or an entirely new path forward, the FDA must, to the best of its ability, better understand its past medical device color additive practices (as well as the variations that have developed within the last twenty or so years), and engage in a dialogue with stakeholders on how it and the medical device industry should consider unlisted color additives currently used in marketed devices in the United States.
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.
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