FDA and Intellectual Property Strategies for Medical Device Technologies
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 ma
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al Property Strategies for Medical Device Technologies
FDA and Intellectual Property Strategies for Medical Device Technologies
Gerald B. Halt • John C. Donch Amber R. Stiles • Lisa Jenkins VanLuvanee Brandon R. Theiss • Dana L. Blue
FDA and Intellectual Property Strategies for Medical Device Technologies
Gerald B. Halt United Plaza Volpe and Koenig, P.C. United Plaza Philadelphia, PA, USA
John C. Donch Volpe and Koenig, P.C. Philadelphia, PA, USA
Amber R. Stiles Miramar Beach, FL, USA
Lisa Jenkins VanLuvanee Facet Life Sciences, Inc. Wayne, PA, USA
Brandon R. Theiss Volpe and Koenig, PC Philadelphia, PA, USA
Dana L. Blue Facet Life Sciences, Inc. Wayne, PA, USA
ISBN 978-3-030-04461-9 ISBN 978-3-030-04462-6 (eBook) https://doi.org/10.1007/978-3-030-04462-6 Library of Congress Control Number: 2018965190 © Springer Nature Switzerland AG 2019 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
Preface
When it comes to inventing, developing, and commercializing medical devices, companies will invariably come to an intersection between business, regulatory compliance, intellectual property, and the law. These areas are diverse, but an understanding of each is absolutely critical to the successful development of a new medical device product. With years of experience as consultants to entrepreneurs, doctors, and medical device companies, the authors of this book have recognized the guidance that is needed and have sought to furnish a guide to issues that are important to medical device companies as they work to bring new medical device technologies to market. Specifically, this book identifies and explains FDA regulatory pathways that are available to medical companies, provides a primer
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