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FDA and Intellectual Property Strategies for Medical Device Technologies

By: Gerald B. Halt,John C. Donch,Amber R. Stiles,Lisa Jenkins VanLuvanee,Brandon R. Theiss,Dana L. Blue

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FDA and Intellectual Property Strategies for Medical Device Technologies

By: Gerald B. Halt,John C. Donch,Amber R. Stiles,Lisa Jenkins VanLuvanee,Brandon R. Theiss,Dana L. Blue

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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Page Count

339

Publisher

Springer

Published Date

ISBN 10

3030044629

ISBN 13

9783030044626

FDA and Intellectual Property Strategies for Medical Device Technologies

By: Gerald B. Halt,John C. Donch,Amber R. Stiles,Lisa Jenkins VanLuvanee,Brandon R. Theiss,Dana L. Blue

Write a review Read reviews Take a Quiz Solve Book Puzzle

FDA and Intellectual Property Strategies for Medical Device Technologies

By: Gerald B. Halt,John C. Donch,Amber R. Stiles,Lisa Jenkins VanLuvanee,Brandon R. Theiss,Dana L. Blue

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.

Average ratings

N/A

5

0%

4

0%

3

0%

2

0%

1

0%

Solve jigsaw puzzle

Age

Page Count

339

Publisher

Springer

Published Date

ISBN 10

3030044629

ISBN 13

9783030044626