Title FDA and intellectual property strategies for medical device technologies / Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss and Dana L. Blue

Published Cham, Switzerland : Springer, [2019]

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Description 1 online resource (xxiv, 333 pages) Contents General overview of development process -- FDA meetings and device testing -- Compiling and submitting your device application -- During and after review -- Patents -- Trademarks -- Trade secrets -- Copyright in medical device technology -- Design protection for medical devices -- Intellectual property issues in medical device labeling and marketing -- Enforcement, infringement, and monetization of intellectual property rights -- Successful implementation of a medical device company's IP strategy -- Tips for avoiding and preventing intellectual property problems -- Successful implementation of a medical device company's regulatory strategy -- Tips for avoiding and preventing regulatory problems -- Potential combined USPTO and FDA regulatory pitfalls Summary 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 also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators. 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 interplay between FDA regulatory review of medical device technology and intellectual property strategy Explores the benefits of protecting, managing and enforcing intellectual property obtained for medical device technology so that innovators can obtain the best possible commercial results from their IP ownership Uses real case studies to illustrate concepts covered Bibliography Includes bibliographical references and index Notes Online resource; title from PDF title page (EBSCO, viewed January 31, 2019) Subject United States. Food and Drug Administration. SUBJECT United States. Food and Drug Administration fast Subject Medical instruments and apparatus -- Law and legislation -- United States Medical technology -- Law and legislation -- United States Intellectual property. Equipment and Supplies Medical Informatics Intellectual Property Drug and Narcotic Control intellectual property. HEALTH & FITNESS -- Holism. HEALTH & FITNESS -- Reference. MEDICAL -- Alternative Medicine. MEDICAL -- Atlases. MEDICAL -- Essays. MEDICAL -- Family & General Practice. MEDICAL -- Holistic Medicine. MEDICAL -- Osteopathy. Medical technology -- Law and legislation Medical instruments and apparatus -- Law and legislation Drug accessibility Intellectual property International trade Medical technology Pharmaceutical policy United States Form Electronic book Author Donch, John C., Jr., author. Stiles, Amber R., author. VanLuvanee, Lisa Jenkins, author Theiss, Brandon R., 1985- author. Blue, Dana L., author ISBN 9783030044626 3030044629 9783030044633 3030044637

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