将医疗设备推向市场的要求。

IF 14.3 1区工程技术 Q1 BIOTECHNOLOGY & APPLIED MICROBIOLOGY

Trends in biotechnology Pub Date : 2024-08-22 DOI:10.1016/j.tibtech.2024.07.016

Eric J Buenz, Victoria M Wallace, Suzanne Levy Friedman

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引用次数: 0

摘要

该书为医疗器械创新者提供了一份路线图，重点介绍了美国监管授权、市场准入和报销战略的基本步骤，侧重于商业成功的战略规划，强调从医疗器械的最初开发开始就应将监管和市场准入方面的考虑因素结合起来。

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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Requirements to bring a medical device to market.

A roadmap for medical device innovators is presented that highlights the essential steps for regulatory authorization, market access, and reimbursement strategies in the USA, with a focus on strategic planning for commercial success, underscoring the integration of regulatory and market access considerations from the initial development of a medical device.

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来源期刊

Trends in biotechnology 工程技术-生物工程与应用微生物

CiteScore

28.60

自引率

1.20%

发文量

198

审稿时长

1 months

期刊介绍： Trends in Biotechnology publishes reviews and perspectives on the applied biological sciences, focusing on useful science applied to, derived from, or inspired by living systems. The major themes that TIBTECH is interested in include: Bioprocessing (biochemical engineering, applied enzymology, industrial biotechnology, biofuels, metabolic engineering) Omics (genome editing, single-cell technologies, bioinformatics, synthetic biology) Materials and devices (bionanotechnology, biomaterials, diagnostics/imaging/detection, soft robotics, biosensors/bioelectronics) Therapeutics (biofabrication, stem cells, tissue engineering and regenerative medicine, antibodies and other protein drugs, drug delivery) Agroenvironment (environmental engineering, bioremediation, genetically modified crops, sustainable development).