Medical Devices Law and Regulation Answer Book 2011–12

September 15, 2011

The Practising Law Institute ("PLI") has released a new Medical Devices Law and Regulation Answer Book 2011–12, edited by Suzan Onel (K&L Gates LLP) and Karen M. Becker (Becker & Associates Consultants).  This Q&A guide is intended to orient and guide those new to the industry, and to be a useful annotated resource for the more experienced regulatory professional.  It has 19 chapters covering a wide range of topics in the life cycle of a medical device, including:

  • Device Premarket Submissions 
  • Post Market Considerations 
  • In Vitro Diagnostic ("IVD") Devices 
  • Interacting with FDA 
  • International Considerations 
  • HIPAA’s Impact on Manufacturers

The book has more than 30 contributors from leading law firms and consulting firms specializing in medical device work.  In the interest of full disclosure, we (proudly) note that Jeff Shapiro, a Director of our firm, contributed Chapter 3 on Device Premarket Submissions.  We also received a free review copy.

The single volume Medical Devices Law and Regulation Answer Book 2011–12 is $235 and is available for a 30-day free examination.

The table of contents is unusually detailed because it shows the questions that the book answers in each chapter.  The table of contents (and other information about the book and the contributing authors) can be found here.  The FDA Law Blog is pleased to offer its readers a 25% discount off the purchase price.  When ordering, contact Andrew Given at 212-824-5887 or and let him know you would like the FDA Law Blog discount.

Categories: Medical Devices