PLI recently published the 2018 edition of Medical Devices Law and Regulation Answer Book, in which more than thirty contributors from various law and consulting firms share their expertise regarding the wide range of topics encountered in this heavily regulated field.

This book provides in-depth coverage of individual FDA programs that govern everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations and more. Presented in a question-and-answer format, this guide also discusses related topics that have a marked impact on the medical devices industry, such as intellectual property, product liability, and reimbursement.

Medical Devices Law and Regulation Answer Book is designed to distill the essential elements of this complex regulatory environment and provide a practical guide to the complexities of FDA regulation of medical devices. It is a practical, in-depth reference for all lawyers, consultants, and companies operating in the medical devices sector, as well as all companies contemplating entertering it .

This updated answer book is available on PLI PLUS, our research database.  If you’d like to order a print copy, please email libraryrelations@pli.edu or call 877.900.5291.