| 书目名称 | FDA and Intellectual Property Strategies for Medical Device Technologies | | 编辑 | Gerald B. Halt,John C. Donch,Dana L. Blue | | 视频video | | | 概述 | Investigates the FDA approval process as it pertains to medical device technology.Address some of the major FDA hurdles that medical device innovators often face while seeking approval.Discusses the i | | 图书封面 |  | | 描述 | This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection.. .This book | | 出版日期 | Book 2019 | | 关键词 | FDA Regulatory Requirements For Medical Devices; Design Protection For Medical Devices; Copyrights In | | 版次 | 1 | | doi | https://doi.org/10.1007/978-3-030-04462-6 | | isbn_ebook | 978-3-030-04462-6 | | copyright | Springer Nature Switzerland AG 2019 |
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发表于 2025-3-21 20:08:49
