FDA and Intellectual Property Strategies for Medical Device

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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 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.
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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.
Country USA
Brand Springer
Manufacturer Springer
Binding Hardcover
ItemPartNumber 34624316
ReleaseDate 2019-01-24
UnitCount 1
EANs 9783030044619

Country	USA
Brand	Springer
Manufacturer	Springer
Binding	Hardcover
ItemPartNumber	34624316
ReleaseDate	2019-01-24
UnitCount	1
EANs	9783030044619

FDA and Intellectual Property Strategies for Medical Device Technologies