Ebook Medical Device Development: Regulation and Law By Jonathan S. Kahan, Hogan Lovells US LLP
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Medical Device Development: Regulation and Law By Jonathan S. Kahan, Hogan Lovells US LLP
Ebook Medical Device Development: Regulation and Law By Jonathan S. Kahan, Hogan Lovells US LLP
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- Sales Rank: #61011 in Books
- Published on: 2014-03-01
- Binding: Hardcover
- 622 pages
Review
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! --Richard Mackenzie, Amazon Verified Purchase
I recently acquired a copy of Jonathan Kahan s book entitled Medical Device Development: Regulation and Law, in its most recent edition. I have been in the regulatory affairs profession for over 23 years now, and can easily navigate websites and references to find the information I need. However, as I was reviewing a recent FDA proposed rule, I found myself repeatedly reaching out to the book as all the information I needed was compiled and easily found in one place, organized by topic, with all needed legislative and regulatory references. Mr. Kahan has done an admirable job in creating this book, and I am thankful to have it on my desk for easy reference when needed. --Tamima Itani, Ph.D., FRAPS, RAC MSVP, Global Regulatory Affairs and Regulatory Compliance, Boston Scientific
About the Author
The book is written by Jonathan S. Kahan, Partner, Hogan Lovells US LLP 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 40 years. Jon is also an Adjunct Professor at the George Washington University Law School teaching medical device law. 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.
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