Medical Device Development: Regulation and Law

- $195.00

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Medical Device Development: Regulation and Law, 2009 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 new 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 newly-released 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.

Approx. 600 pages
Regular Price $195
Student Price $95

Reader Testimonial:  

"This is one of the best books written on the subject of regulatory affairs for the medical device industry. This book is a great tool whether you are a seasoned regulatory professional or a front line supervisor. Kahan is in my opinion on his way to becoming the Juran of the regulatory field."
Scott Baker, CQT, CQE, CQA, Supplier Quality Engineer II, Smith & Nephew, Inc.  

About the author:
The book is written by Jonathan S. Kahan, Partner, Hogan & Hartson in Washington, D.C. Jon is a co-director of the firm''s food, drug, medical device, and agriculture group, and has been practicing in FDA law for 35 years. His practice focuses primarily on assisting medical device companies in navigating the U.S. Food and Drug Administration (FDA) regulatory process. He also has an extensive practice in combination products, which includes combinations of drugs, devices, and biologics. In addition to the daily counseling of clients in FDA-related matters, he represents many clients in administrative hearings and trials, and in the federal courts. Jon has published numerous law review and other articles concerning FDA regulatory issues.