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Medical Devices Law and Regulation Answer Book (2021 Edition)

Author(s): Suzan Onel, Karen M. Becker
Practice Area: Enforcement (Health care), Enforcement (Life sciences), Health care, Life sciences, Medical devices, Regulation and compliance (Life sciences), Regulation and compliance (Technology), Technology
Date: Aug 2020 i Other versions can be found in the Related Items tab.
ISBN: 9781402435942
PLI Item #: 293665

Medical Devices Law and Regulation Answer Book walks you through the current regulatory requirements governing medical devices and describes every aspect from pre-market requirements for specific types of devices to post-market regulation and ongoing government enforcement and investigation. The organization of this text broadly follows the typical life cycle of a device and covers a broad range of topics, including many that are not commonly included in surveys of this field.

  • Overview of the legal framework of FDA regulation of medical devices
  • Pre-market considerations, including clinical trials, IDEs, 510(k) and PMA submissions, 3D printed devices, devices used with regenerative therapies, combination products, restricted devices, custom devices, and radiological products
  • Special FDA COVID-19 policies, emergency use authorizations, cybersecurity, laboratory-developed tests, new technologies and medical device licensing
  • Manufacturing compliance, FDA inspections, andin vitro diagnostics
  • The Quality System Regulation, post-market issues, including device promotion, adverse event reporting, and international considerations
  • Interacting with FDA and government enforcement and device commercialization and related issues, including industry-supported scientific activities, intellectual property, licensing, reimbursement, privacy, product liability, preemption, criminal enforcement, and oversight by other federal agencies

With contributions from more than two dozen of the world’s leading experts in medical device regulation, this comprehensive work distills the complexities of FDA medical device regulation into a single practical guide that will be of value to virtually everyone doing business in the medical device sector — including lawyers, consultants, companies operating in the medical device sector, and individual or entity contemplating entry into this field.

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.