Medical Device Development

Medical Device Development: Regulation and Law [Hardcover]

Author: Jonathan S. Kahan | Language: English | ISBN: 1882615921 | Format: PDF, EPUB

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Medical Device Development: Regulation and Law
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Medical Device Development: Regulation and Law, 2nd Edition, is the must-have resource for the novice or veteran medical device regulatory affairs professional. This practical reference provides the most comprehensive and updated analysis of US medical device and diagnostics development and approval requirements anywhere. This book also features in-depth analysis on how emerging developments and trends are reshaping medical device and combination product regulations in the US. The second edition of this popular and authoritative resource addresses the latest regulatory and legal developments that guide how medical devices are developed today: * The Medical Device User Fee and Modernization Act of 2002, including user fees, third party inspections, reprocessed single use devices, and the establishment of the Office of Combination Products. * The Food and Drug Administration Amendments Act of 2007, including unique device identifiers, ClinicalTrials.gov registration, pediatric device promotion, and postmarket surveillance and medical device reporting changes. * The current and future landscape of electronic 510(k) and PMA submissions. New chapters and features in the second edition include: * Medical Device Compliance and Postmarket Surveillance requirements. * Quality System Regulation, including management controls, design controls, risk analysis and corrective and preventive action, and other QSR provisions. * In Vitro Diagnostics, including IVD clinical studies, ASR regulation, LDTs, CLIA, and IUO/RUO requirements. * Combination Products and Product Jurisdiction, including a description of FDA s jurisdictional decision-making for single entity products, the establishment of the Office of Combination Products and its jurisdiction and processes, with a detailed discussion of the new definition of the primary mode of action. * A glossary and comprehensive index of terms and concepts.

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• Hardcover: 550 pages
• Publisher: Parexel Intl Corp; 2nd edition (August 17, 2009)
• Language: English
• ISBN-10: 1882615921
• ISBN-13: 978-1882615926
• Product Dimensions: 6.4 x 9.4 inches
• Shipping Weight: 2.4 pounds (View shipping rates and policies)
• Amazon Best Sellers Rank: #475,343 in Books (See Top 100 in Books)

Great book for a beginner learning about process, or an experienced practitioner in the field. I used prior addition, until i realized it was updated - i testify on matters of value in the field of medical devices, and nothing helps the court understand faster - than a text book you can cite documenting the process of a 510(k) application or a PMA!

By Richard Mackenzie

I purchased this book for school and learned so much from it that I'm keeping it and not selling it back. If you have limited knowledge and are in the Industry of Biotechnology and want to learn about Medical Device Regulations etc. this is the book for you.

By MAB

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