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Medical Devices Law and Regulation Answer Book (2017 Edition)

Author(s): Suzan Onel, Karen M. Becker
Practice Area: Health care, Life sciences, Medical devices, Regulation and compliance (Health care), Regulation and compliance (Life sciences)
Date: Nov 2016 i Other versions can be found in the Related Items tab.
ISBN: 9781402427749
PLI Item #: 172971

In Medical Devices Law and Regulation Answer Book, more than thirty contributors from various law and consulting firms share their expertise regarding the laws and regulations governing medical devices.  This book provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations. It provides practical guidance on how to handle everyday questions on a wide variety of topics, as well as what issues are likely to arise and how to avoid them. This question-and-answer guide also discusses related topics that have a marked impact on the medical devices industry, such as intellectual property, product liability, and reimbursement.

The Medical Devices Law and Regulation Answer Book is designed to distill the essential elements of this complex regulatory environment and provide in a single resource 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 entry into the heavily regulated world of medical devices.

With almost 30 years of experience, Suzan Onel advises FDA-regulated companies on regulatory, compliance, and enforcement issues involving medical devices, foods, dietary supplements, over-the-counter drugs, cosmetics and consumer products. She regularly advises international and domestic manufacturers, distributors, and researchers on market entry strategies, labeling and promotional activities, regulatory compliance, recalls and field corrections, and enforcement defense. Ms. Onel assists clients with the preparation of FDA submissions, including 510(k) premarket notifications, premarket approval applications (PMAs), food additive petitions, GRAS self-affirmations and notifications, food contact notifications, new dietary ingredient notifications, and adverse event reports. Ms. Onel’s experience includes representing clients before the U.S. Food and Drug Administration, the Federal Trade Commission, the U.S. Department of Agriculture, the Bureau of Alcohol, Tobacco, and Firearms, the National Advertising Division of the Better Business Bureaus, and similar international and state bodies.

Ms. Onel’s practice also includes FDA due diligence investigations and advising companies and private equity/venture capital investors on transactional matters involving life science company acquisition, divestment and capital growth as well as supplier contracts and clinical research agreements.


Karen M. Becker, Ph.D. joined Precision for Medicine in December 2012 as Managing Director of Translational and Regulatory Sciences, a Center of Excellence established to support research and development, commercialization programs, and regulatory approvals and com pliance for new health care products. Dr. Becker is an industry leader with over twenty­five years of experience serving hundreds of clients in a broad range of therapeutic areas, with a focus on scientific and regulatory services to companies operating at the intersection of science and public policy. Successful resolution of client matters is achieved through application of sound science, reliance on leading clinical and scientific expertise, and a commitment to outstanding quality and service. Prior to Precision, Dr. Becker was the Founder and Chief Executive Officer of Becker & Associates Consulting, Inc., a leading full­service scientific and regulatory affairs consulting firm, until its acquisition. She has published original research in pharmacology and drug development, numerous publications on FDA regulation, and a textbook on 
 the design of clinical trials for medical devices. Dr. Becker is an Adjunct Associate Professor at Georgetown University, where she teaches public health policy and biotechnology management. She received a Bachelor of Science in Biological Chemistry from the University of Maryland at College Park, and a Ph.D. in Pharmacology from the University of North Carolina School of Medicine.