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引用次数: 0
摘要
美国食品和药物管理局(FDA)的510(k)计划基于实质等效审查,是目前需要上市前审查的医疗器械进入市场的主要途径。实质等效性审查受到了很多批评,但本文的结论是,它是一种强大的监管工具,允许FDA适当地确保广泛的中等风险器械满足合理保证安全性和有效性的法定要求。本文详细研究了实质等效性审查,着眼于其历史发展,操作法律框架,FDA为达到实质等效性确定而遵循的具体决策步骤,以及该系统在促进医疗器械上市前审查的效率,可预测性和适应性方面的优势。这篇文章反驳了美国医学研究所(Institute of Medicine)取消实质等同审查的呼吁,并反驳了另一位批评者的发现,即实质等同审查导致严重召回的比例不成比例。本文建议,一个更好的公共510(k)数据库将提高实质等同审查的可预测性。文章最后呼吁对一个基本健全的体系进行有针对性的改革,而不是像批评者建议的那样全盘谴责。
Substantial Equivalence Premarket Review: the Right Approach for Most Medical Devices.
The Food and Drug Administration (FDA)'s 510(k) program based upon substantial equivalence review is by far the dominant pathway to market among medical devices requiring premarket review. Substantial equivalence review has been much criticized, but this article concludes that it is a powerful regulatory tool allowing FDA to appropriately ensure that the broad range of moderate risk devices meet the statutory requirement of reasonable assurance of safety and effectiveness. The article examines substantial equivalence review in detail, looking at its historical development, the operative legal framework, the specific decision steps FDA follows to reach a substantial equivalence determination, and the strengths of the system in fostering efficiency, predictability, and adaptability in the premarket review of medical devices. The article rebuts the Institute of Medicine's call to scrap substantial equivalence review, and rebuts another critic's finding that substantial equivalence review results in a disproportionate share of serious recalls. The article suggests that a better public 510(k) database would improve the predictability of substantial equivalence review. The article concludes by calling for targeted reform of a basically sound system rather than wholesale condemnation as critics have suggested.
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.