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Medical Devices Law and Regulation Answer Book (2017 Edition)

Author(s): Suzan Onel, Karen M. Becker
Practice Area: Health Care, Intellectual Property
Date: Nov 2016 i Previous editions(s) can be found in the Related Items tab.
ISBN: 9781402427749
PLI Item #: 172971

In Medical Devices Law and Regulation Answer Book, more than thirty contributors from various law and consulting firms share their expertise regarding the laws and regulations governing medical devices.  This book provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations. It provides practical guidance on how to handle everyday questions on a wide variety of topics, as well as what issues are likely to arise and how to avoid them. This question-and-answer guide also discusses related topics that have a marked impact on the medical devices industry, such as intellectual property, product liability, and reimbursement.

The Medical Devices Law and Regulation Answer Book is designed to distill the essential elements of this complex regulatory environment and provide in a single resource a practical guide to the complexities of FDA regulation of medical devices. It is a practical in-depth reference for all lawyers, consultants, and companies operating in the medical devices sector, as well as all companies contemplating entry into the heavily regulated world of medical devices.