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 fir...

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Bibliographic Details
Main Authors: Halt, Gerald B., Donch, John C. (Author), Stiles, Amber R. (Author), VanLuvanee, Lisa Jenkins (Author)
Format: eBook
Language:English
Published: Cham Springer International Publishing 2019, 2019
Edition:1st ed. 2019
Subjects:
Online Access:
Collection: Springer eBooks 2005- - Collection details see MPG.ReNa
Table of Contents:
  • Introduction
  • Development of A New Medical Device
  • Determining If A Medical Device Technology Is FDA Regulated
  • Basic FDA Regulatory Requirements For Medical Devices
  • Other Regulatory Consideration For Medical Devices
  • Benefits of Having FDA Approval
  • Patents
  • Trademarks and Trade Dress
  • Trade Secrets
  • Copyrights 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 IP and Regulatory Pitfalls