PLI Publishes 2021 Edition of Medical Devices Law and Regulation Answer Book, Co-Edited by KKB Partner Suzan Onel and Chapters Authored by KKB Partners

The Practicing Law Institute (PLI) recently published the 2021 Edition of its Medical Devices Law and Regulation Answer Book.  KKB Partner Suzan Onel co-edited the treatise.  It is a comprehensive and highly accessible text that provides guidance from some of the world’s leading experts in medical device law and regulation.  KKB is proud to have contributed to multiple chapters.  Partner Suzan Onel co-authored the chapter on combination products and authored the chapter on software and digital health.  KKB Partners KS Reagan and Will Woodlee co-authored the chapter on postmarket considerations, and KKB Partners Suzan Onel and Jacqueline J. Chan co-authored the chapters on continuing medical education and industry supported scientific activities and the separate chapter on radiological devices, restricted devices, custom devices, 3D printed devices, device accessories, and devices used with regenerative therapies.  PLI graciously offers clients and friends of KKB a 20% discount on the treatise if ordered before January 31, 2021.  Order at  For more information, see the Answer Book’s Table of Contents (both abbreviated and extended) and Foreword.