9783030044619-3030044610-FDA and Intellectual Property Strategies for Medical Device Technologies

FDA and Intellectual Property Strategies for Medical Device Technologies

ISBN-13: 9783030044619
ISBN-10: 3030044610
Edition: 1st ed. 2019
Author: Halt, Gerald B., Donch, John C., Stiles, Amber R., VanLuvanee, Lisa Jenkins, Theiss, Brandon R., Blue, Dana L.
Publication date: 2019
Publisher: Springer
Format: Hardcover 357 pages
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Book details

ISBN-13: 9783030044619
ISBN-10: 3030044610
Edition: 1st ed. 2019
Author: Halt, Gerald B., Donch, John C., Stiles, Amber R., VanLuvanee, Lisa Jenkins, Theiss, Brandon R., Blue, Dana L.
Publication date: 2019
Publisher: Springer
Format: Hardcover 357 pages

Summary

Acknowledged authors Halt, Gerald B., Donch, John C., Stiles, Amber R., VanLuvanee, Lisa Jenkins, Theiss, Brandon R., Blue, Dana L. wrote FDA and Intellectual Property Strategies for Medical Device Technologies comprising 357 pages back in 2019. Textbook and eTextbook are published under ISBN 3030044610 and 9783030044619. Since then FDA and Intellectual Property Strategies for Medical Device Technologies textbook was available to sell back to BooksRun online for the top buyback price or rent at the marketplace.

Description

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.

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